VOICE: Values and Options in Cancer Care

Not Applicable

Completed

Conditions: Cancer

Interventions: Behavioral: Communication training and coaching

Registration Number: NCT01485627

Lead Sponsor: University of Rochester

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 485

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Communication training and coaching	Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Primary Outcome Measures

Name	Time	Method
Mean Patient-centered Communication in Advanced Cancer Score	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13	7 months	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.
Aim 2 Patient Well-being	3 years	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.
Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians	3 years	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.
Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life	3 years	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.
Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment	7 months	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.