Rutgers Cancer Institute of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903-2681
Focus Group (Phase 1) Eligibility Criteria:
Nine focus groups (three from each site) will be conducted with data from each group being used to inform and refine the subsequent groups. At each site, the three focus groups will reflect different treatment modalities: Group 1 – Radical Prostatectomy;
Group 2 – Radiation Therapy; Group 3 – Either therapy. Focus groups will consist of racially and ethnically diverse prostate cancer survivors (N=90), with some individual interviews occurring if needed. Eligibility for this phase includes:
User Testing (Phase 2) Eligibility Criteria
A total of 30 prostate cancer survivors (10 from each site) will provide feedback on the VSRCPC components. Eligibility includes:
Usability Testing (Phase 3) Eligibility Criteria
A total of 15 participants matching the characteristics of most prostate cancer survivors will provide feedback on the VSRC-PC components or prototype. Because this study phase will assess the functionality of the program prototype, this phase does not require prostate cancer
survivors to serve as participants. Eligibility includes:
RCT (Phase 4) Eligibility Criteria:
The target sample (N=600) will be men who have recently been treated for prostate cancer. A multi-ethnic survivor group will be recruited from all three participating sites. According to the tumor registry data, on average a total of 1000 eligible prostate cancer patients are seen per year at the three recruitment sites. Of these, about 50% (n=500) are expected to have Internet access . Based on our prior experience with the prostate population , we assume that 48% of eligible patients will agree to enroll in the study, yielding a total of approximately 240 participants per year at the three recruitment sites. We therefore conservatively estimate that we can accrue 20 participants per month over a 30‑month period across the three sites to reach our goal of 600 participants. In addition, if unanticipated problems with accrual occur, we will have ready access to recruit survivors through FCCC and CINJ partner hospitals. This added source of accrual will provide us with a significant cushion, which has not been figured into our accrual calculations. We also project that we will retain approximately 80% of the participants whom we recruit, allowing us to conservatively estimate that 480 participants will complete the study. Power analysis indicates that with 480 participants, the study will be powered to detect a modest effect size (0.1) with at least 84% statistical power (see Section 7.4 of the protocol). With regard to minority recruitment, we project that approximately 20% of the recruited participants will be African American (n=120) men.
ENROLLMENT TARGET: 735
Available only through CTSU Registration
This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms.
The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4‑month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase.
Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies. Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months.
After study entry, patients are followed up every 3 months for 2 years.
National Enrollment to Date: 284/464
Available only through CTSU Registration