Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT04149704
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Videos for Advance Care Planning in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer_snaman@dfci.harvard.edu', 'phone': '617632-5548', 'title': 'Jennifer Snaman', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion; average of 3-months, ending 5/2022', 'eventGroups': [{'id': 'EG000', 'title': 'ACP Video Decision Aid - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACP Video Decision Aid - Caregiver', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Care - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care-: Verbal description of the three types of care', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Care - Caregiver', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care-: Verbal description of the three types of care', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACP Video Decision Aid', 'description': '* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire\n* 10 minute video decision aid: describing the goals-of-care options\n* Follow telephone interview at 3 months to assess goals of care\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}, {'id': 'OG001', 'title': 'Standard Care', 'description': '* In-person interview where the patient and caregiver dyad will randomized to either the video aid intervention or standard care and complete baseline questionnaire\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care: Verbal description of the three types of care'}], 'classes': [{'title': 'Concordance in goals of care pre intervention', 'categories': [{'title': 'Number of dyads with concordant goals of care', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Number of dyads with disconcordant goals of care', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Concordance in goals of care post intervention', 'categories': [{'title': 'Number of dyads with concordant goals of care', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Number of dyads with disconcordant goals of care', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Concordance in goals of care 3 months post intervention', 'categories': [{'title': 'Number of dyads with concordant goals of care', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Number of dyads with disconcordant goals of care', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 months', 'description': 'AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed as dyad. If one individual of the dyad did not complete study procedures, those results were not analyzed. One AYA assigned to standard care did not have a caregiver that was able to participate. One AYA of a caregiver assigned to video decision aid was unable to participate. As the unit of measurement was the DYAD, these two individuals (one standard arm, one video) were not analyzed although they did complete enrollment and baseline and follow-up assessments (but not 3 month)'}, {'type': 'SECONDARY', 'title': 'Increased Advance Care Planning (ACP) Conversations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACP Video Decision Aid - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}, {'id': 'OG001', 'title': 'Standard Care - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care-: Verbal description of the three types of care'}], 'classes': [{'title': 'Change in number of AYAs that engaged in ACP conversations following the intervention to 3-months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Change in number of AYAs that had ACP documentation from baseline to 3 months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 3 months', 'description': 'Patients randomized to the video will have more ACP conversations and documentation after 3 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AYA participants that had data at 3-month follow-up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care - Patients', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care: Verbal description of the three types of care'}, {'id': 'FG001', 'title': 'Standard Care - Caregivers', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care: Verbal description of the three types of care'}, {'id': 'FG002', 'title': 'ACP Video Decision Aid - Patients', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}, {'id': 'FG003', 'title': 'ACP Video Decision Aid - Caregivers', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}], 'periods': [{'title': 'Baseline and Immediately Post', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'comment': '3 month follow up time point', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Three Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Not completed as dyad (one member of dayd did not complete initial timepoint so withdrawn from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patient recruited while in clinic; shift to almost all virtual recruitment in late 2020. Eligible individuals received a latter explaining the study and were called one week later to provide further details and determine interest.', 'preAssignmentDetails': 'All enrolled participant completed a baseline survey prior to randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care: Verbal description of the three types of care'}, {'id': 'BG001', 'title': 'Standard Care - Caregiver', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months\n\nUsual Care: Verbal description of the three types of care'}, {'id': 'BG002', 'title': 'ACP Video Decision Aid - Patient', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}, {'id': 'BG003', 'title': 'ACP Video Decision Aid - Caregiver', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months\n\nACP video decision aid: 10 minute video decision aid describing the goals-of-care options'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '5.6', 'groupId': 'BG002'}, {'value': '43.0', 'spread': '13.8', 'groupId': 'BG003'}, {'value': '37.6', 'spread': '11.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'participants were enrolled as AYA and caregiver dyads; presented here as individual participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-18', 'size': 360862, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-08T16:44', 'hasProtocol': True}, {'date': '2020-10-07', 'size': 459457, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-07T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2019-10-31', 'resultsFirstSubmitDate': '2022-10-16', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-06', 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased Concordance Rate in Stated Goals of Care (Life-prolonging Medical Care, Selective Medical Care, or Comfort-focused Care)', 'timeFrame': 'baseline, 3 months', 'description': 'AYA with advanced cancer and caregivers randomized to the video will have higher concordance in their stated goals of care between patients and caregivers at 3 month compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Increased Advance Care Planning (ACP) Conversations', 'timeFrame': 'Baseline and 3 months', 'description': 'Patients randomized to the video will have more ACP conversations and documentation after 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancer'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '37433434', 'type': 'DERIVED', 'citation': 'Snaman JM, Feifer D, Helton G, Chang Y, El-Jawahri A, Volandes AE, Wolfe J. A Pilot Randomized Trial of an Advance Care Planning Video Decision Support Tool for Adolescents and Young Adults With Advanced Cancer. J Natl Compr Canc Netw. 2023 Jul;21(7):715-723.e17. doi: 10.6004/jnccn.2023.7021.'}]}, 'descriptionModule': {'briefSummary': "This study is a randomized trial of adolescent and young adults with advanced cancer and their caregivers to assess preferences for care in advanced cancer. This research study is examining the similarities and differences between patient's and caregiver's goals of cancer care.\n\nThe names of the study interventions involved in this study may include:\n\n* Questionnaires\n* Video\n* Phone Interview", 'detailedDescription': "The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n\\- Patients and their caregivers will be randomized into the same group; either ACP video decision aid intervention or usual care.\n\n* Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision aid intervention or usual care.\n* Participants will be in this research study for up to 3 months with only 2 study visits.\n* It is expected that about 100 people (50 patients and 50 caregivers) will take part in this research study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital, the inpatient or outpatient clinics of Massachusetts General Hospital, or virtually. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures if recruited in-person. If participants are enrolled and complete study procedures virtually, they will provide verbal consent before initiating study procedures.\n\nIf in-person visits cannot be conducted, eligible participants will be still be mailed a pre-notice letter that offers the chance for participants to opt-out or opt-in via email or phone call. After one week, we will call participants we have not heard from and ask if they would consider participating.\n\nPatient Eligibility criteria will include patients who are:\n\ni) Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, marked by progression or relapsed disease) ii) Aged between 18-39, which is the legal age for completing an ACP document (e.g., POLST/MOLST); iii) Speak English; and iv) Have a caregiver or identified surrogate decision maker who is able to participate.\n\nv) Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital\n\nExclusion criteria will include:\n\ni) A diagnosis of low-grade glioma given the fact that progressive or relapsed low grade may not be clinically characterized as advanced disease and associated poor prognosis.\n\nii) Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned); iii) Psychological state not appropriate for ACP discussions as determined by the primary oncologist; and, iv) Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire"}, 'identificationModule': {'nctId': 'NCT04149704', 'briefTitle': 'Videos for Advance Care Planning in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Videos for Advance Care Planning in Young Adults', 'orgStudyIdInfo': {'id': '19-409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACP video decision aid', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* 10 minute video decision aid: describing the goals-of-care options .\n* Follow telephone interview at 3 months', 'interventionNames': ['Behavioral: ACP video decision aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.\n\n* In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care\n* Receive the verbal description of the three types of care\n* Follow telephone interview at 3 months', 'interventionNames': ['Other: Usual Care-']}], 'interventions': [{'name': 'ACP video decision aid', 'type': 'BEHAVIORAL', 'description': '10 minute video decision aid describing the goals-of-care options', 'armGroupLabels': ['ACP video decision aid']}, {'name': 'Usual Care-', 'type': 'OTHER', 'description': 'Verbal description of the three types of care', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jennifer Snaman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer Snaman, MD, MS', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}