Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 7:18 PM
Study NCT ID:
NCT01485627
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VOICE: Values and Options in Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ronald_epstein@urmc.rochester.edu', 'phone': '5855069484', 'title': 'Ronald Epstein MD', 'organization': 'UNIVERSITY OF ROCHESTER DEPARTMENT OF FAMILY MEDICINE'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a study of terminally ill patients and all deaths were expected.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'description': 'There were 91 deaths in the intervention arm for the patients and 1 caregiver death. These were terminally ill patients. Adverse events were not collected for the physicians.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention-patients', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 91, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control-patients', 'description': 'Patients will receive usual care', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'deathsNumAffected': 96, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intervention- Caregivers', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intervention-caregivers', 'description': 'Patients will receive usual care', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Patient-centered Communication in Advanced Cancer Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference in difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.62', 'estimateComment': 'Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.', 'groupDescription': 'The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \\[APPC\\], Verona VR-CoDES, Prognostic and Treatment Choices \\[PTCC\\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': "We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.", 'unitOfMeasure': 'standardized score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was assessed in patients only.'}, {'type': 'SECONDARY', 'title': 'Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Communication', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control: Usual Care', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '7 months', 'description': 'The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This instrument was used with caregivers only.'}, {'type': 'SECONDARY', 'title': 'Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was assessed in patients only.'}, {'type': 'SECONDARY', 'title': 'Aim 2 Patient Well-being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Communication', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control: Usual Care', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.', 'unitOfMeasure': 'standardized score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was assessed in patients only.'}, {'type': 'SECONDARY', 'title': 'Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Communication', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control: Usual Care', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.677', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '7 months', 'description': 'SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sf-12 was given to the caregivers only.'}, {'type': 'SECONDARY', 'title': 'Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients will receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Health care utilization was assessed in patients only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention: Communication', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'FG001', 'title': 'Control: Usual Care', 'description': 'Patients will receive usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '139 patients and 105 caregivers', 'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '244'}, {'comment': '142 patients and 99 caregivers', 'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '241'}]}, {'type': 'Allocated Caregivers: Total', 'achievements': [{'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '105'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '99'}]}, {'type': 'Bereaved Caregivers: Total', 'achievements': [{'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '63'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '64'}]}, {'type': 'Bereaved Caregivers: 1 Month', 'achievements': [{'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '51'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '51'}]}, {'type': 'Bereaved Caregivers: 2 Month Completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '49'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '52'}]}, {'type': 'Bereaved Caregivers: 7 Month Completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '48'}, {'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '130 patients and 48 caregivers', 'groupId': 'FG000', 'numUnits': '19', 'numSubjects': '178'}, {'comment': '135 patients and 49 caregivers', 'groupId': 'FG001', 'numUnits': '19', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '66'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Patient withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Patient died', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient lost to followup', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Caregiver withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Caregiver lost to follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Caregiver died', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'caregiver was not bereaved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}], 'typeUnitsAnalyzed': 'physicians', 'recruitmentDetails': '54 physicians were assessed for eligibility. Of these 2 were ineligible and 9 refused participation. 43 physicians were included in the pre-randomized phase and of these 2 withdrew and 3 did not enroll enough patients. Patients from 38 physicians were included for the cluster randomized clinical trial phase of the study.', 'preAssignmentDetails': '233 caregivers and 316 patients were consented. 204 caregivers were allocated and 127 of them were bereaved. 24 caregivers failed screening and 5 withdrew during screening. 26 patients failed screening and 9 withdrew during screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention: Communication Training', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.\n\nCommunication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.'}, {'id': 'BG001', 'title': 'Control: Usual Care', 'description': 'Patients will receive usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '11', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Continuous age was only collected for the patients. Categorical age was only collected for the caregivers.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age continuous was collected for the patients.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall number of participants is the total of caregivers and patients for each arm.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Overall baseline participants includes both the patients and caregivers'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of Enrollment for patients only', 'unitOfMeasure': 'participants', 'populationDescription': 'Region of Enrollment for patients only'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of enrollment for caregivers only', 'unitOfMeasure': 'participants', 'populationDescription': 'Region of enrollment for caregivers only'}], 'populationDescription': 'Patients: 130 for the intervention and 135 for the control arms, who completed the audio-recorded office visit. Caregivers: 50 for the intervention and 53 for the control arms, who were bereaved and completed the month 2 and/or month 7 assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-20', 'size': 510133, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-21T14:17', 'hasProtocol': True}, {'date': '2016-03-12', 'size': 370950, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-21T14:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2011-11-30', 'resultsFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-08', 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Patient-centered Communication in Advanced Cancer Score', 'timeFrame': '3 years', 'description': "We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08."}], 'secondaryOutcomes': [{'measure': 'Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13', 'timeFrame': '7 months', 'description': 'The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.'}, {'measure': 'Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians', 'timeFrame': '3 years', 'description': 'Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.'}, {'measure': 'Aim 2 Patient Well-being', 'timeFrame': '3 years', 'description': 'Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.'}, {'measure': 'Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment', 'timeFrame': '7 months', 'description': 'SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': 'Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life', 'timeFrame': '3 years', 'description': 'Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Communication', 'prognosis'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '27612178', 'type': 'DERIVED', 'citation': 'Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.'}, {'pmid': '23570278', 'type': 'DERIVED', 'citation': 'Hoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.', 'detailedDescription': 'The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Physicians\n\n* Currently in clinical practice at participating institutions\n* Oncologist that cares for patients with solid tumors\n* Not planning to leave the practice during the next 6 months\n\nInclusion Criteria: Patients\n\n* Currently a patient of an enrolled physician\n* Age 21 years or older\n* Diagnosis of advanced cancer\n* Able to understand spoken English (study personnel will read materials to low literacy patients)\n\nInclusion Criteria: Caregivers\n\n* Caregiver of a patient currently enrolled in the study\n* Age 21 years or older\n* Able to understand spoken English (study personnel will read materials to low literacy patients)\n\nExclusion Criteria: Physicians\n\n* Non Physicians and physicians who are not oncologists\n* Oncologists who exclusively care for patients with hematological malignancies\n* Prior involvement in health-related coaching interventions\n\nExclusion Criteria: Patients\n\n* Unable to complete orally-administered surveys in English\n* Hospitalized or in hospice care at the time of recruitment\n* Prior involvement in health-related coaching interventions\n* Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma\n\nExclusion Criteria: Caregiver\n\nUnable to complete orally-administered surveys in English'}, 'identificationModule': {'nctId': 'NCT01485627', 'acronym': 'VOICE', 'briefTitle': 'VOICE: Values and Options in Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer', 'orgStudyIdInfo': {'id': '35388'}, 'secondaryIdInfos': [{'id': 'R01CA140419-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01CA140419-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.', 'interventionNames': ['Behavioral: Communication training and coaching']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will receive usual care'}], 'interventions': [{'name': 'Communication training and coaching', 'type': 'BEHAVIORAL', 'description': 'Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Ronald Epstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ronald Epstein', 'investigatorAffiliation': 'University of Rochester'}}}}