VOICE: Values and Options in Cancer Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Communication training and coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physicians Currently in clinical practice at participating institutions Oncologist that cares for patients with solid tumors Not planning to leave the practice during the next 6 months Inclusion Criteria: Patients Currently a patient of an enrolled physician Age 21 years or older Diagnosis of advanced cancer Able to understand spoken English (study personnel will read materials to low literacy patients) Inclusion Criteria: Caregivers Caregiver of a patient currently enrolled in the study Age 21 years or older Able to understand spoken English (study personnel will read materials to low literacy patients) Exclusion Criteria: Physicians Non Physicians and physicians who are not oncologists Oncologists who exclusively care for patients with hematological malignancies Prior involvement in health-related coaching interventions Exclusion Criteria: Patients Unable to complete orally-administered surveys in English Hospitalized or in hospice care at the time of recruitment Prior involvement in health-related coaching interventions Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma Exclusion Criteria: Caregiver Unable to complete orally-administered surveys in English

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit. | Behavioral: Communication training and coaching<br>* Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.<br>|
| No Intervention: Control<br>Patients will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Communication, prognosis