MP44-19 ADHERENCE TO A BEHAVIOR MODIFICATION INTERVENTION FOR PROSTATE CANCER: THE MEN′S EATING AND LIVING (MEAL) STUDY (CALGB 70807 [ALLIANCE])

Abstract

INTRODUCTION AND OBJECTIVES: Clinical guidelines endorsing lifestyle‐based therapies for prostate cancer survivors are based on expert opinion and observational studies. There are limited data on the efficacy of structured, behavior‐based interventions to affect beneficial change in urological cancers. METHODS: As part of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]), we assessed adherence to an intervention promoting vegetable intake in men on active surveillance for prostate cancer. Eligible patients were randomized (1:1) to a validated, telephone‐based counseling intervention or a control condition in which they received printed materials from the Prostate Cancer Foundation (PCF) recommending consumption of a healthy diet. Intervention participants were assigned to a counselor who encouraged consumption of ≥ 7 daily vegetable‐fruit servings. During follow‐up, an independent team evaluated the diets of participants by telephone interview using the Nutrition Data Systems for Research (NDS‐R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN). Fasting blood samples were collected at baseline, 12 months, and 24 months and analyzed for plasma carotenoids‐biomarkers of vegetable intake and putative anti‐carcinogens‐using high‐performance liquid chromatography. Changes in mean daily intakes of total vegetables, crucifers, tomato products, and fat and in plasma carotenoid concentrations were assessed using two‐sample t‐tests. RESULTS: Baseline characteristics were balanced across the two study arms. Mean (SD) age was 63.5 (6.4) years and PSA 4.9 (2.1) ng/mL. Fifty (11%) participants were African‐American. There were no significant differences between groups for age, race/ethnicity, region, time elapsed since prostate cancer diagnosis, PSA, clinical stage, or tumor grade. Compared to control, the intervention significantly increased from baseline‐and sustained through 24‐month follow‐upvegetable (+71% vs. +11% servings/day, p < 0.0001), crucifer (+222% vs. +8% servings/day, p < 0.0001), carotenoid (+114% vs. +4% mcg/day, p < 0.0001), and lycopene (+130% vs. ‐10% mcg/ day, p < 0.0001) consumption and blood carotenoid levels (+24% vs. +10% μmol/L, p = 0.01). CONCLUSIONS: The MEAL Study is the first randomized clinical trial of a behavior modification intervention in prostate cancer survivors. These data demonstrate that scalable, robust, lifestylefocused behavior change is feasible in a urological cancer population.