Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-09 @ 9:44 AM
Study NCT ID:
NCT03824158
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yas28@pitt.edu', 'phone': '415-254-9958', 'title': 'Yael Schenker, MD, MAS, FAAHPM', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 60 months', 'eventGroups': [{'id': 'EG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 0, 'seriousNumAtRisk': 203, 'deathsNumAffected': 112, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.", 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 1, 'seriousNumAtRisk': 197, 'deathsNumAffected': 116, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Web-based Advance Care Planning (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the web-based advance care planning arm.', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the facilitated advance care planning arm.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Suicidal ideation', 'notes': 'During conversation during a non-study visit, the patient expressed suicidal ideation, and appeared distraught. Referred to psych services by the clinical team, and offered the Resolve Crisis number. Event not considered related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Homicidal ideation', 'notes': 'During conversation during a non-study visit, the patient expressed homicidal ideation, and appeared distraught. Referred to psych services by the clinical team, and offered the Resolve Crisis number. Event not considered related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Advance Care Planning Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': '15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants that completed 12 week outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] talked with \\[participant\'s\\] family or friends about the kind of medical care \\[participant\\] would want if \\[participant\\] were very sick or near the end of life?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants that completed 12 week outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Had Advance Care Planning Discussions With Physicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] talked with \\[participant\'s\\] doctor about the kind of medical care \\[participant\\] would want if \\[participant\\] were very sick or near the end of life?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants that completed 12 week outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Completed an Advance Directive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] completed a living will or advance directive?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants that completed 12 week outcomes assessment.'}, {'type': 'SECONDARY', 'title': 'Documented Care Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}], 'classes': [{'title': 'New advance directive or living will', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'New Physician Orders for Life-sustaining Treatment (POLST) form', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'New Code Status', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'New Goals of Care discussion', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Advance directive or living will', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'POLST', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Code Status', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Goals of Care discussion', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caregiver Depression Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the web-based advance care planning arm.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the facilitated advance care planning arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.34', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '3.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caregiver Anxiety Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Web-based Advance Care Planning (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the web-based advance care planning arm.'}, {'id': 'OG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the facilitated advance care planning arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.94', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '3.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Bereaved caregivers will be asked "In \\[participant\'s\\] opinion, to what extent were \\[the patient\'s\\] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients\' wishes a great deal."', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Receipt of Goal-concordant End-of-life Care - Place of Death', 'timeFrame': 'during bereavement, up to 60 months', 'description': "Bereaved caregivers will be asked about patient's preferred and actual places of death, with questions separated in the survey to minimize conscious comparison. Receipt of goal-concordant end-of-life care - place of death will be defined as patients dying in their preferred location.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Quality of End-of-life Care', 'timeFrame': 'during bereavement, up to 60 months', 'description': '13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Post-traumatic Stress Symptoms', 'timeFrame': 'during bereavement, up to 60 months', 'description': '22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Depression Symptoms', 'timeFrame': 'bereavement, up to 60 months', 'description': 'Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Caregiver Anxiety Symptoms', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - Chemotherapy', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - ICU', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - Hospice', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether the participant was admitted to hospice (Y/N)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - Hospice < 3 Days', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether the participant was admitted to hospice for \\< 3 days (Y/N)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - Hospice Length of Stay', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'For participants admitted to hospice, investigators will measure number of days in hospice.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - Hospitalizations', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure number of hospitalizations in the last month of life', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthcare Utilization at End of Life - ED Visits', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure number of emergency department visits in the last month of life', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Advance Care Planning Implementation Costs', 'timeFrame': 'through study completion, up to 5 years', 'description': 'Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'FG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}, {'id': 'FG002', 'title': 'Web-based Advance Care Planning (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the web-based advance care planning arm.'}, {'id': 'FG003', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the facilitated advance care planning arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '102'}, {'groupId': 'FG003', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'Recruitment occurred from August 1, 2019 until July 14, 2023. Patients were enrolled from 8 oncology clinics within the University of Pittsburgh Medical Center Hillman Cancer Center Network in western Pennsylvania. Patients were encouraged but not required to identify a caregiver, defined as the primary adult (family member or friend) involved in their care and best able to participate in the study, as assessed by the patient. Patients without a willing caregiver participant were not excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Web-based Advance Care Planning (PATIENTS)', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.\n\nWeb-based advance care planning: Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.'}, {'id': 'BG001', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (PATIENTS)', 'description': "Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.\n\nFacilitated advance care planning (in-person or telephonic): The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences."}, {'id': 'BG002', 'title': 'Web-based Advance Care Planning (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the web-based advance care planning arm.'}, {'id': 'BG003', 'title': 'Facilitated Advance Care Planning (In-person or Telephonic) (CAREGIVERS)', 'description': 'Enrolled caregivers of patients randomized to the facilitated advance care planning arm.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '67.8', 'spread': '10', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '11', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '13.6', 'groupId': 'BG002'}, {'value': '61.9', 'spread': '13.5', 'groupId': 'BG003'}, {'value': '67.9', 'spread': '10.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '391', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '281', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '663', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}, {'value': '622', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': '< High school', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'High school diploma or GED', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}, {'title': 'Some college or college degree', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '349', 'groupId': 'BG004'}]}, {'title': 'Graduate or professional degree', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their highest level of formal education completed at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Current Marital Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Never married', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}, {'title': 'Married', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '461', 'groupId': 'BG004'}]}, {'title': 'Widowed', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}, {'title': 'Divorced/Separated', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their current marital status at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Ability to manage on income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Cannot make ends meet', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Just manage to get by', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': 'Have enough with a little extra', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '248', 'groupId': 'BG004'}]}, {'title': 'Money is not a problem', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their ability to manage on their income at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Religion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Agnostic/Atheist/No religion', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Buddhist', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Catholic', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '276', 'groupId': 'BG004'}]}, {'title': 'Other Christian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'Hindu', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Jewish', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Muslim', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Protestant', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': 'Declined to answer', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their religion at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Religious importance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Not at all important', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Not too important', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}, {'title': 'Fairly important', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '178', 'groupId': 'BG004'}]}, {'title': 'Very important', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '339', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported how important religion is to them at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Confidence filling out medical forms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Not at all', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'A little bit', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Somewhat', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': 'Extremely', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '351', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported how confident they are filling out medical forms at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'How many other people live in your household?', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}, {'title': '1', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '407', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '4+', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported how many other people currently live in their household at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'Current employment status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Working full-time', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}, {'title': 'Working part-time', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Unemployed', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Retired', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '359', 'groupId': 'BG004'}]}, {'title': 'Homemaker (never worked for pay)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Disability', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their current employment status at the time of enrollment.', 'unitOfMeasure': 'Participants'}, {'title': 'HADS Survey Depression Subscale Scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4.62', 'spread': '3.44', 'groupId': 'BG000'}, {'value': '4.69', 'spread': '3.52', 'groupId': 'BG001'}, {'value': '4.22', 'spread': '3.54', 'groupId': 'BG002'}, {'value': '3.96', 'spread': '3.43', 'groupId': 'BG003'}, {'value': '4.65', 'spread': '3.48', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale designed to measure anxiety and depression. Subscale scores range 0-21, with higher scores indicating higher anxiety or depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HADS Survey Anxiety Subscale Scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '672', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.22', 'spread': '3.69', 'groupId': 'BG000'}, {'value': '5.15', 'spread': '3.73', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '4.1', 'groupId': 'BG002'}, {'value': '7.44', 'spread': '4.43', 'groupId': 'BG003'}, {'value': '5.19', 'spread': '3.71', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale designed to measure anxiety and depression. Subscale scores range 0-21, with higher scores indicating higher anxiety or depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current living situation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'title': 'In a home I (or my family) own', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG004'}]}, {'title': 'In a home I (or my family) rent', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG004'}]}, {'title': 'In a Board and Care home', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'In an Assisted Living Facility', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'In a Nursing Home', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Other/Unsure', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants self-reported their current living situation at the time of enrollment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Current living situation was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Cancer type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Genitourinary', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Brain', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Breast', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Gynecologic', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Gastrointestinal', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Hepatobiliary', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Head and Neck', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Lung', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'Melanoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Pancreatic', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Prostate', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer type was collected at the time of enrollment by patient self-report, followed by querying the oncologist and/or checking the medical record to confirm accuracy of the self-reported cancer type.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Cancer type was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Time since first diagnosed with cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Less than one month ago', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': '≥ 1 month but < 6 months ago', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': '≥ 6 months but < 1 year ago', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG004'}]}, {'title': '≥ 1 year but < 2 years ago', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '≥ 2 years but < 5 years ago', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG004'}]}, {'title': '≥ 5 years ago', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients self-reported the amount of time since they were first diagnosed with cancer.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Time since first diagnosed with cancer was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Time receiving care from current oncologist', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Less than one month', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': '≥ 1 month but < 6 months', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG004'}]}, {'title': '≥ 6 months but < 1 year', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG004'}]}, {'title': '≥ 1 year but < 2 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG004'}]}, {'title': '≥ 2 years but < 5 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '≥ 5 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients self-reported the amount of time they have been receiving care from their current oncologist.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Time receiving care from current oncologist was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'ECOG Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'title': 'ECOG Score - 0', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'ECOG Score - 1', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG004'}]}, {'title': 'ECOG Score - 2', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Eastern Cooperative Oncology Group (ECOG) Performance Status scale describes how well cancer patients can function in daily life. Scores range 0-5; higher scores indicate greater functional impairment. Scores were collected for the study by querying treating oncologist. 0=Fully active, able to carry on all pre-disease performance w/o restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.', 'unitOfMeasure': 'Participants', 'populationDescription': 'ECOG score was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Patient reported previously completing a living will or advance directive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Binary question, YES or NO, with YES indicating the patient reported previously completed a living will or advance directive.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Previous living will or advance directive completion was only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Patient reported previously having advance care planning discussions with caregivers', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Binary question, YES or NO, with YES indicating the patient reported previously having advance care planning discussions with caregivers.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Previous advance care planning discussions were only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Patient reported previously having advance care planning discussions with physicians', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Binary question, YES or NO, with YES indicating the patient reported previously having advance care planning discussions with physicians.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Previous advance care planning discussions were only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Prior living will or advance directive in the medical record', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The patient's electronic medical record was reviewed to determine if a living will or advance directive was uploaded and available to view prior to the study intervention.", 'unitOfMeasure': 'Participants', 'populationDescription': 'Living will or advance directive information was collected only for patients.'}, {'title': 'Prior POLST form in the medical record', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The patient's electronic medical record was reviewed to determine if a Physician Orders for Life-Sustaining Treatment (POLST) form was uploaded and available to view prior to the study intervention.", 'unitOfMeasure': 'Participants', 'populationDescription': 'POLST form information was collected only for patients.'}, {'title': 'Advance Care Planning (ACP) Engagement Survey Total Scores', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.66', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '3.74', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '3.70', 'spread': '0.98', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Advance Care Planning Engagement scores were only collected for enrolled patients. Caregivers were not included in this measure.'}, {'title': 'Relationship to enrolled patient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Spouse/partner', 'measurements': [{'value': '90', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}, {'title': 'Child', 'measurements': [{'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Parent', 'measurements': [{'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Sibling', 'measurements': [{'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Friend', 'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Refused to answer', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers self-reported their relationship to the enrolled patient at the time of enrollment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Relationship to enrolled patient was only collected for caregivers.'}, {'title': 'Caregiver lives with the patient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Binary question, YES or NO, with YES indicating the caregiver reported living with the patient at the time of enrollment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Living with the enrolled patient was only collected for caregivers.'}, {'title': 'Current care provider for the patient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '241', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Binary question, YES or NO, with YES indicating the caregiver reported being a current care provider for the patient at the time of enrollment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Care provider status was only collected for caregivers.'}, {'title': 'Average days per week providing care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.33', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '5.59', 'spread': '2.3', 'groupId': 'BG003'}, {'value': '5.46', 'spread': '2.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Caregivers self-reported the average number of days per week they provide care to the patient.', 'unitOfMeasure': 'days per week', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Average days providing care was only collected for caregivers.'}, {'title': 'Average hours per day providing care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.92', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '7.15', 'spread': '7.9', 'groupId': 'BG003'}, {'value': '7.03', 'spread': '8.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Caregivers self-reported the average number of hours per day they provide care to the patient.', 'unitOfMeasure': 'hours per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Average hours providing care was only collected for caregivers.'}, {'title': 'Currently providing care for anyone else', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers self-reported if they are currently providing care for anyone other than the enrolled patient.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Providing care for anyone else was only collected for caregivers.'}], 'populationDescription': 'Some baseline measures were only collected for either patients or caregivers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-17', 'size': 511331, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-11T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-16', 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Healthcare Utilization at End of Life - Chemotherapy', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether chemotherapy was administered within the last 2 weeks of life (Y/N)'}, {'measure': 'Healthcare Utilization at End of Life - ICU', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether participant was admitted to the intensive care unit in the last 30 days of life (Y/N)'}, {'measure': 'Healthcare Utilization at End of Life - Hospice', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether the participant was admitted to hospice (Y/N)'}, {'measure': 'Healthcare Utilization at End of Life - Hospice < 3 Days', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure whether the participant was admitted to hospice for \\< 3 days (Y/N)'}, {'measure': 'Healthcare Utilization at End of Life - Hospice Length of Stay', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'For participants admitted to hospice, investigators will measure number of days in hospice.'}, {'measure': 'Healthcare Utilization at End of Life - Hospitalizations', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure number of hospitalizations in the last month of life'}, {'measure': 'Healthcare Utilization at End of Life - ED Visits', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Investigators will measure number of emergency department visits in the last month of life'}, {'measure': 'Advance Care Planning Implementation Costs', 'timeFrame': 'through study completion, up to 5 years', 'description': 'Investigators will assess advance care planning implementation costs by tracking staff time spent on each intervention arm. Staff time costs for each intervention will be estimated by multiplying staff training and patient care time related to the intervention in hours by the average hourly wage for US nursing and social work staff of comparable levels.'}], 'primaryOutcomes': [{'measure': 'Advance Care Planning Engagement', 'timeFrame': '12 weeks', 'description': '15-item Advance Care Planning (ACP) engagement survey assesses ACP processes related to choosing a medical decision maker, discussing and documenting preference for care at end of life, flexibility for surrogate decision making, and asking questions of medical providers. A single summary score will be reported (range 0-5 with higher scores indicating higher engagement).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Have Had Advance Care Planning Discussions With Caregivers', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] talked with \\[participant\'s\\] family or friends about the kind of medical care \\[participant\\] would want if \\[participant\\] were very sick or near the end of life?"'}, {'measure': 'Number of Participants Who Have Had Advance Care Planning Discussions With Physicians', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] talked with \\[participant\'s\\] doctor about the kind of medical care \\[participant\\] would want if \\[participant\\] were very sick or near the end of life?"'}, {'measure': 'Number of Participants Who Have Completed an Advance Directive', 'timeFrame': '12 weeks', 'description': '"Has \\[participant\\] completed a living will or advance directive?"'}, {'measure': 'Documented Care Goals', 'timeFrame': '12 weeks', 'description': 'Investigators will assess documented care goals by reviewing medical records for any care goals documented since baseline (Yes/No).'}, {'measure': 'Caregiver Depression Symptoms', 'timeFrame': '12 weeks', 'description': 'Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.'}, {'measure': 'Caregiver Anxiety Symptoms', 'timeFrame': '12 weeks', 'description': 'Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.'}, {'measure': 'Receipt of Goal-concordant End-of-life Care - Patient Wishes Followed', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Bereaved caregivers will be asked "In \\[participant\'s\\] opinion, to what extent were \\[the patient\'s\\] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients\' wishes a great deal."'}, {'measure': 'Receipt of Goal-concordant End-of-life Care - Place of Death', 'timeFrame': 'during bereavement, up to 60 months', 'description': "Bereaved caregivers will be asked about patient's preferred and actual places of death, with questions separated in the survey to minimize conscious comparison. Receipt of goal-concordant end-of-life care - place of death will be defined as patients dying in their preferred location."}, {'measure': 'Quality of End-of-life Care', 'timeFrame': 'during bereavement, up to 60 months', 'description': '13-item Caregiver Evaluation of Quality of End-of-Life Care (CEQUEL) scale. A single summary score will be reported (range of scores 13-26, with higher scores indicating better perceived quality of care).'}, {'measure': 'Caregiver Post-traumatic Stress Symptoms', 'timeFrame': 'during bereavement, up to 60 months', 'description': '22-item Impact of Events Scale-revised has a scoring range from 0-88, with higher scores indicating more post-traumatic stress symptoms.'}, {'measure': 'Caregiver Depression Symptoms', 'timeFrame': 'bereavement, up to 60 months', 'description': 'Depression subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver depression symptoms at 12 weeks and bereavement. The HADS depression subscale scores range from 0 to 21, with higher scores indicating more distress.'}, {'measure': 'Caregiver Anxiety Symptoms', 'timeFrame': 'during bereavement, up to 60 months', 'description': 'Anxiety subscale of the 14-item Hospital Anxiety and Depression Scale (HADS) will be used to assess caregiver anxiety symptoms at 12 weeks and bereavement. The anxiety subscale scores range from 0 to 21, with higher scores indicating more distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer, advance care planning'], 'conditions': ['Cancer', 'Advance Care Planning']}, 'referencesModule': {'references': [{'pmid': '40106743', 'type': 'DERIVED', 'citation': 'Schenker Y, Belin SC, Wang T, Sudore RL, Hammes B, Arnold RM, Flowers R, Chiu E, Hall J, Dudley-Morrissey Y, Ferrell B, Crowley-Matoka M, Brufsky A, Chu E, Gorantla V, Mehta D, Thomas R, Yee M, White D. Facilitated Versus Patient-Directed Advance Care Planning Among Patients With Advanced Cancer: A Randomized Clinical Trial. JCO Oncol Pract. 2025 Oct;21(10):1447-1457. doi: 10.1200/OP-25-00046. Epub 2025 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to identify the most effective and efficient advance care planning (ACP) strategy for patients with advanced cancer.\n\nThe specific aims are to:\n\nAim 1. Compare the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes.\n\nAim 2. Assess implementation costs and the effects of in-person, facilitated ACP and web-based ACP on healthcare utilization at end of life.\n\nAim 3. Identify contexts and mechanisms that influence the effectiveness of in-person, facilitated ACP versus web-based ACP.', 'detailedDescription': "Study investigators will conduct a single-blind, patient-level randomized trial to compare the effectiveness of two different patient-facing advance care planning (ACP) interventions. Investigators will enroll 400 patients with advanced cancer and their family caregivers to receive either (1) in-person discussions with trained facilitators or (2) web-based ACP using interactive videos. Because these approaches have never been compared directly, it is unclear whether one form of advance care planning is more potent, and if so, for whom and under what circumstances.\n\nAim 1 compares the effectiveness of in-person, facilitated ACP versus web-based ACP on patient and family caregiver outcomes (ACP engagement, ACP discussions, advance directive completion, goal attainment, and caregiver psychological symptoms). Aim 2 assesses implementation costs of each intervention and effects on healthcare utilization at end of life. Aim 3 identifies contexts and mechanisms influencing the effectiveness of each approach. Primary patient outcomes will be assessed at 12 weeks. Participants will be followed until 12 weeks after the patient's death or completion of the 48-month data collection period, whichever occurs first. In-depth interviews with patients, caregivers, and clinicians will begin in Year 2 of the grant and continue until thematic saturation is reached."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n1. 18 years of age or older\n2. Solid tumor\n3. The oncologist "would not be surprised" if the patient died within the next year\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2\n5. Planning to receive ongoing care at a participating oncology clinic\n6. Willing to participate in either a web-based or facilitated program\n\nPatient Exclusion Criteria:\n\n1. Does not speak English\n2. Inability to consent, using a validated teach-back method\n3. Hematologic malignancy\n4. No phone for additional study contacts and follow-up interviews\n5. Unable to participate in advance care planning, as assessed by clinician\n6. Unable to complete the baseline interview\n\nPatients will be able to identify and enroll a caregiver, designated by the patient as the primary family member or friend involved in their care and best able to participate in the study.\n\nCaregiver Inclusion criteria:\n\n1. 18 years of age or older\n2. Family member or friend of an eligible patient\n3. Primary person involved in patient\'s care and best able to participate in the study, as assessed by patient\n\nCaregiver Exclusion criteria:\n\n1. Does not speak English\n2. No phone for additional study contacts and follow-up interviews\n3. Unable to complete the baseline interview'}, 'identificationModule': {'nctId': 'NCT03824158', 'briefTitle': 'Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Patient-centered and Efficacious Advance Care Planning in Cancer: the PEACe Comparative Effectiveness Trial', 'orgStudyIdInfo': {'id': 'STUDY19080337'}, 'secondaryIdInfos': [{'id': '1R01CA235730-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA235730-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Facilitated advance care planning (in-person or telephonic)', 'description': 'Patients randomized to this arm will participate in in-person or telephonic facilitated advance care planning (ACP) discussions using the Respecting Choices model.', 'interventionNames': ['Behavioral: Facilitated advance care planning (in-person or telephonic)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Web-based advance care planning', 'description': 'Patients randomized to this arm will participate in web-based ACP via the PREPARE website.', 'interventionNames': ['Behavioral: Web-based advance care planning']}], 'interventions': [{'name': 'Facilitated advance care planning (in-person or telephonic)', 'type': 'BEHAVIORAL', 'description': "The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.", 'armGroupLabels': ['Facilitated advance care planning (in-person or telephonic)']}, {'name': 'Web-based advance care planning', 'type': 'BEHAVIORAL', 'description': 'Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.', 'armGroupLabels': ['Web-based advance care planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Yael Schenker, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yael Schenker, MD, MAS', 'investigatorAffiliation': 'University of Pittsburgh'}}}}