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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
485
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
University of Rochester
Rochester, New York, United States
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.
Time frame: 3 years
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.
Time frame: 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.
Time frame: 3 years
Aim 2 Patient Well-being
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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.
Time frame: 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.
Time frame: 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.
Time frame: 3 years