Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.

Communication training and coaching

Ronald Epstein, MD

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.

VOICE: Values and Options in Cancer Care

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

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

University of Rochester

Professor

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.

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.

Intervention-patients

Control-patients

Intervention- Caregivers

Intervention-caregivers

Intervention: Communication Training

Control: Usual Care

Total

Age categorical was collected for the bereaved caregivers only who completed the month 2 and/or month 7 assessment.

Age, Categorical

Continuous age was only collected for the patients. Categorical age was only collected for the caregivers.

Age continuous was collected for the patients.

Age, Continuous

patients

Caregivers

The overall number of participants is the total of caregivers and patients for each arm.

Sex: Female, Male

Overall baseline participants includes both the patients and caregivers

Race (NIH/OMB)

United States

Region of Enrollment

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.

This was a study of terminally ill patients and all deaths were expected.

Ronald Epstein MD

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.

Intervention

Control

This outcome measure was assessed in patients only.

Mean Patient-centered Communication in Advanced Cancer Score

Intervention: Communication

This instrument was used with caregivers only.

Spots Global Cancer Trial Database for VOICE: Values and Options in Cancer Care

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