Trial Outcomes & Findings for VOICE: Values and Options in Cancer Care (NCT NCT01485627)

Last Updated: 2019-01-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

485 participants

Primary outcome timeframe

3 years

Results posted on

2019-01-10

Participant Flow

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.

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.

Unit of analysis: physicians

Participant milestones

Participant milestones
Measure	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.	Control: Usual Care Patients will receive usual care
Overall Study STARTED	244 19	241 19
Overall Study Allocated Caregivers: Total	105 19	99 19
Overall Study Bereaved Caregivers: Total	63 19	64 19
Overall Study Bereaved Caregivers: 1 Month	51 19	51 19
Overall Study Bereaved Caregivers: 2 Month Completed	49 19	52 19
Overall Study Bereaved Caregivers: 7 Month Completed	48 19	49 19
Overall Study COMPLETED	178 19	184 19
Overall Study NOT COMPLETED	66 0	57 0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control: Usual Care Patients will receive usual care
Overall Study Patient withdrew	6	5
Overall Study Patient died	3	1
Overall Study Patient lost to followup	0	1
Overall Study Caregiver withdrew	3	3
Overall Study Caregiver lost to follow up	11	12
Overall Study Caregiver died	1	0
Overall Study caregiver was not bereaved	42	35

Baseline Characteristics

Region of enrollment for caregivers only

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 years

Population: This outcome measure was assessed in patients only.

Outcome measures

Outcome measures
Measure	Intervention n=130 Participants 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.	Control n=135 Participants Patients will receive usual care
Mean Patient-centered Communication in Advanced Cancer Score	0.16 standardized score on a scale Standard Deviation 0.81	-0.01 standardized score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 7 months

Population: This instrument was used with caregivers only.

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.

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants 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.	Control n=49 Participants Patients will receive usual care
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13	19.3 units on a scale Standard Deviation 5.9	20.6 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 3 years

Population: This outcome measure was assessed in patients only.

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.

Outcome measures

Outcome measures
Measure	Intervention n=130 Participants 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.	Control n=135 Participants Patients will receive usual care
Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians	2.2 units on a scale Standard Deviation 1.5	2.5 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 3 years

Population: This outcome measure was assessed in patients only.

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.

Outcome measures

Outcome measures
Measure	Intervention n=130 Participants 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.	Control n=135 Participants Patients will receive usual care
Aim 2 Patient Well-being	-0.01 standardized score on a scale Standard Deviation 0.73	-0.07 standardized score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: 7 months

Population: Sf-12 was given to the caregivers only.

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.

Outcome measures

Outcome measures
Measure	Intervention n=48 Participants 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.	Control n=49 Participants Patients will receive usual care
Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment	48.9 units on a scale Standard Deviation 9.6	47.9 units on a scale Standard Deviation 11.5

SECONDARY outcome

Timeframe: 3 years

Population: Health care utilization was assessed in patients only.

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.

Outcome measures

Outcome measures
Measure	Intervention n=130 Participants 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.	Control n=135 Participants Patients will receive usual care
Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life	0.76 units on a scale Standard Deviation 1.1	0.58 units on a scale Standard Deviation 0.9

Adverse Events

Intervention-patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 91 deaths

Control-patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 96 deaths

Intervention- Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Intervention-caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald Epstein MD

UNIVERSITY OF ROCHESTER DEPARTMENT OF FAMILY MEDICINE

Phone: 5855069484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention: Communication Training n=180 Participants 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.	Control: Usual Care n=188 Participants Patients will receive usual care	Total n=368 Participants Total of all reporting groups
Region of Enrollment United States	50 participants n=50 Participants • Region of enrollment for caregivers only	53 participants n=53 Participants • Region of enrollment for caregivers only	265 participants n=265 Participants • Region of Enrollment for patients only
Age, Categorical <=18 years	0 Participants n=50 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	0 Participants n=53 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	0 Participants n=103 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.
Age, Categorical Between 18 and 65 years	21 Participants n=50 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	27 Participants n=53 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	48 Participants n=103 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.
Age, Categorical >=65 years	29 Participants n=50 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	26 Participants n=53 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.	55 Participants n=103 Participants • Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.
Age, Continuous	64.2 years STANDARD_DEVIATION 11.7 • n=130 Participants • Age continuous was collected for the patients.	64.5 years STANDARD_DEVIATION 11 • n=135 Participants • Age continuous was collected for the patients.	64.4 years STANDARD_DEVIATION 11.4 • n=265 Participants • Age continuous was collected for the patients.
Sex: Female, Male patients · Female	76 Participants n=130 Participants • The overall number of participants is the total of caregivers and patients for each arm.	70 Participants n=135 Participants • The overall number of participants is the total of caregivers and patients for each arm.	146 Participants n=265 Participants • The overall number of participants is the total of caregivers and patients for each arm.
Sex: Female, Male patients · Male	54 Participants n=130 Participants • The overall number of participants is the total of caregivers and patients for each arm.	65 Participants n=135 Participants • The overall number of participants is the total of caregivers and patients for each arm.	119 Participants n=265 Participants • The overall number of participants is the total of caregivers and patients for each arm.
Sex: Female, Male Caregivers · Female	25 Participants n=50 Participants • The overall number of participants is the total of caregivers and patients for each arm.	29 Participants n=53 Participants • The overall number of participants is the total of caregivers and patients for each arm.	54 Participants n=103 Participants • The overall number of participants is the total of caregivers and patients for each arm.
Sex: Female, Male Caregivers · Male	25 Participants n=50 Participants • The overall number of participants is the total of caregivers and patients for each arm.	24 Participants n=53 Participants • The overall number of participants is the total of caregivers and patients for each arm.	49 Participants n=103 Participants • The overall number of participants is the total of caregivers and patients for each arm.
Race (NIH/OMB) patients · American Indian or Alaska Native	0 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · Asian	0 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · Native Hawaiian or Other Pacific Islander	0 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · Black or African American	0 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · White	116 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	119 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	235 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · More than one race	0 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) patients · Unknown or Not Reported	14 Participants n=130 Participants • Overall baseline participants includes both the patients and caregivers	16 Participants n=135 Participants • Overall baseline participants includes both the patients and caregivers	30 Participants n=265 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · American Indian or Alaska Native	0 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · Asian	0 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · Black or African American	0 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · White	44 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	46 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	90 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · More than one race	0 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	0 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers
Race (NIH/OMB) Caregivers · Unknown or Not Reported	6 Participants n=50 Participants • Overall baseline participants includes both the patients and caregivers	7 Participants n=53 Participants • Overall baseline participants includes both the patients and caregivers	13 Participants n=103 Participants • Overall baseline participants includes both the patients and caregivers