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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA140419-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
|
| Control | No Intervention | Patients will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication training and coaching | Behavioral | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Patient-centered Communication in Advanced Cancer Score | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 | 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. | 7 months |
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Inclusion Criteria: Physicians
Inclusion Criteria: Patients
Inclusion Criteria: Caregivers
Exclusion Criteria: Physicians
Exclusion Criteria: Patients
Exclusion Criteria: Caregiver
Unable to complete orally-administered surveys in English
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Epstein, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27612178 | Derived | 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. | |
| 23570278 |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Communication | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
| FG001 | Control: Usual Care | Patients will receive usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Communication Training | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Patient-centered Communication in Advanced Cancer Score | 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. | This outcome measure was assessed in patients only. | Posted | Mean | Standard Deviation | standardized score on a scale | 3 years |
|
3 years
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention-patients | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
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This was a study of terminally ill patients and all deaths were expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Epstein MD | UNIVERSITY OF ROCHESTER DEPARTMENT OF FAMILY MEDICINE | 5855069484 | ronald_epstein@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2016 | Aug 21, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2016 | Aug 21, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians | 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. | 3 years |
| Aim 2 Patient Well-being | 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. | 3 years |
| Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment | 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. | 7 months |
| Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life | 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. | 3 years |
| Derived |
| 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. |
| Patient lost to followup |
|
| Caregiver withdrew |
|
| Caregiver lost to follow up |
|
| Caregiver died |
|
| caregiver was not bereaved |
|
| Control: Usual Care |
Patients will receive usual care |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Continuous age was only collected for the patients. Categorical age was only collected for the caregivers. | Age continuous was collected for the patients. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The overall number of participants is the total of caregivers and patients for each arm. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Overall baseline participants includes both the patients and caregivers | Count of Participants | Participants |
|
| Region of Enrollment | Region of Enrollment for patients only | Region of Enrollment for patients only | Number | participants |
|
| Region of Enrollment | Region of enrollment for caregivers only | Region of enrollment for caregivers only | Number | participants |
|
| OG000 | Intervention | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. |
| OG001 | Control | Patients will receive usual care |
|
|
|
| Secondary | Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13 | 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. | This instrument was used with caregivers only. | Posted | Mean | Standard Deviation | units on a scale | 7 months |
|
|
|
|
| Secondary | Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians | 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. | This outcome measure was assessed in patients only. | Posted | Mean | Standard Deviation | units on a scale | 3 years |
|
|
|
|
| Secondary | Aim 2 Patient Well-being | 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. | This outcome measure was assessed in patients only. | Posted | Mean | Standard Deviation | standardized score on a scale | 3 years |
|
|
|
| Secondary | Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment | 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. | Sf-12 was given to the caregivers only. | Posted | Mean | Standard Deviation | units on a scale | 7 months |
|
|
|
|
| Secondary | Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life | 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. | Health care utilization was assessed in patients only. | Posted | Mean | Standard Deviation | units on a scale | 3 years |
|
|
|
|
| 91 |
| 139 |
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | Control-patients | Patients will receive usual care | 96 | 142 | 0 | 142 | 0 | 142 |
| EG002 | Intervention- Caregivers | Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. Communication training and coaching: Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. | 1 | 105 | 0 | 105 | 0 | 105 |
| EG003 | Intervention-caregivers | Patients will receive usual care | 0 | 99 | 0 | 99 | 0 | 99 |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|