|Grant Number:||5R21CA131754-02 Interpret this number|
|Primary Investigator:||Jones, Randy|
|Organization:||University Of Virginia|
|Project Title:||Decision Making in Patients with Advanced Prostate Cancer|
DESCRIPTION (provided by applicant): Many patients with advanced prostate cancer and their caregivers struggle with treatment decisions, such as when to terminate cancer-directed treatment. Patient preparation for consequential decisions, including termination of cancer-directed treatment, is not well handled in most clinical practices. Specific aims for this study will be to: 1) determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with hormone refractory prostate cancer (and their caregivers) anticipating cancer-directed treatment; and 2) To gather preliminary data for testing the hypothesis that patients with advanced prostate cancer (and their caregivers), who receive a decision aid to enhance decision-making skills about cancer treatment, will demonstrate (a) increased quality decision making, (b) decreased decisional conflict, and (c) increased decisional satisfaction. This pilot study, in preparation for a prospective, randomized clinical trial, will gather preliminary data to test decision-making aid for 45 patient/caregiver pairs. It will be conducted at two sites: one at the University of Virginia in Virginia and the other at Memorial Sloan-Kettering Cancer Center in New York. A mixed-method approach will be used: 1) a single blind, pretest/posttest design will measure a time period that includes two single- event decisions over the course of their treatment until cancer-directed treatment is terminated; and 2) a qualitative retrospective design will allow exploring the experiences of both patients and caregivers separately in a 1-hour interview at the completion of the study. A stratified block randomization design will be used for race (African- American and Caucasian/Other). There will be two groups: 30 pairs in the enhanced care/intervention group (EC); 15 pairs in the usual care/control group (UC). EC will receive a decision aid with seven components: 1) social support, 2) anticipatory guidance, 3) adherence to the patient's preference for participation in treatment decision making, 4) a quality decision-making process tutorial, 5) normalization (using a CD home kit), 6) structured time with oncology professionals to discuss difficult decisions, and 7) values clarification of 2 decisions throughout treatment (using balance sheets). Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The primary outcome measures are quality decision making, decisional conflict, and decisional satisfaction. Two panels (decision making and prostate cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during two clinic visits. Generalized linear models will be used for data analysis for the quantitative component; saturation of themes will be used for the qualitative component. Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer, specifically hormone-resistant prostate cancer (HRPC), is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. Exploring the use of a decision aid that focuses on HRPC and helps patients participate in their treatment decisions about their health is very important. This study will test a decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about treatment that affects patients' quality of life.