S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II

OBJECTIVES:

Primary

• To determine the feasibility of a 12-month community-based combined physical activity and dietary change weight-loss intervention in overweight and sedentary female breast and colorectal cancer survivors recruited via the Southwest Oncology Group (SWOG).
• To estimate the effect size of the intervention on weight loss at 12 months.

Secondary

• To measure changes in anthropometric measures from baseline (body mass index [BMI], waist and hip circumference) at 6 and 12 months and body composition (% body fat as assessed by dual-energy X-ray absorptiometry [DXA] scan) at 12 months.
• To measure changes in minutes spent per week in moderate-to-vigorous aerobic activity from baseline using Curves attendance records and a 7-day physical activity assessment at 6 and 12 months.
• To measure changes from baseline to 6 and 12 months in dietary intake of carotenoids via serum carotenoid measures.
• To assess changes from baseline to 6 and 12 months in perceived benefit of dietary change, physical activity, and weight loss after a cancer diagnosis.
• To measure changes from baseline in metabolic and hormonal biomarkers associated with breast and colorectal cancer recurrence risk (fasting insulin, fasting glucose, hemoglobin A1C, bioavailable estradiol, free testosterone, and adiponectin) at 6 and 12 months.
• To assess changes from baseline in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function using the PROMISE-43 at 6 and 12 months.
• To assess baseline predictors (medical history, health behaviors, quality of life) of subjects who adhere to and complete the intervention.
• To assess the diversity of subjects who enroll and complete the intervention.
• To assess the availability and acceptability of the Curves fitness centers at 12 months.
• To explore changes in DNA methylation.
• To assess the intervention and study process via open-ended interviews with SWOG sites and Curves franchises.
• To measure changes in anthropometric measures and assess feasibility of extended follow-up at 24 and 36 months.
• To assess the safety of the Curves® fitness centers for this population by assessing self-reported changes in lymphedema and any injuries as measured at 6 and 12 months.