S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors
- Conditions
- Breast CancerPainFatigueAnxiety DisorderDepressionCognitive/Functional EffectsColorectal CancerPsychosocial Effects of Cancer and Its TreatmentWeight Changes
- Registration Number
- NCT01453452
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Physical activity, diet, and counseling may help breast and colorectal cancer survivors to lose weight and improve their quality of life.
PURPOSE: This phase II trial studies how well exercise, diet, and counseling work in improving physical activity and weight loss in overweight women who are breast and colorectal cancer survivors.
- Detailed Description
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.
OUTLINE: Participants are stratified according to type of cancer (breast vs colorectal).
Participants are instructed to practice 30-45 minutes of medium-to-hard exercise 5-7 days a week at a Curves fitness center (paid by study) or outside Curves for 12 months. Participants receive written materials on physical activity guidelines for survivors and a pedometer to track their physical activity outside Curves. They also receive the Curves Fitness \& Weight Management Plan and are instructed to follow a "higher carbohydrate" diet plan, which promotes a 1,500 kcal/day diet that is high in fruit and vegetables consisting of 30% protein, 45% carbohydrates, and 25% fat. In addition, participants receive the dietary guidelines for cancer survivors, which recommend eating 5 or more servings of fruit/vegetables per day, a diet high in whole grains, low in saturated fat, low in sugary foods, and low in alcohol. Participants receive 14 behavioral-counseling sessions by telephone with the goal to increase intervention adherence and participation retention. Each session lasts 40 minutes and occurs weekly on weeks 1-5 and then every 6 weeks by month 6. Participants receive monthly email newsletters with health tips and motivational messages to encourage adherence and retention to the study program. Counselors also conduct three 24-hour dietary recall assessments and 1 physical activity assessment at 6 and 12 months.
Participants complete a PROMIS-43 quality-of-life questionnaire at 6 and 12 months via internet, mail, or telephone.
Participants also undergo blood sample collection at baseline and at 6 and 12 months for fasting glucose and insulin tests, and biomarker studies. Anthropometric measurements (height, weight, waist, and hip circumference) are also collected.
After completion of study intervention, participants are followed up at 24 and 36 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention 1 year from registration Increase in fruit and vegetable consumption by 1 full serving per day (not including iceberg lettuce, potatoes, or fruit juices) OR reduce caloric intake by 100 kcal/day 1 year from registration
- Secondary Outcome Measures
Name Time Method Changes in anthropometric measures (weight, BMI, waist circumference, hip circumference) 1 year from registration Changes in body composition (% body fat as assessed by DXA scan at 12 months only) 1 year from registration Changes in dietary intake patterns based on three separate 24-hour diet recalls 1 year from registration Changes in minutes spent per week in moderate-to-vigorous intensity aerobic activity using Curves attendance records and a 7-day physical activity recall assessment 1 year from registration Changes 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) 3 years Changes in anxiety, depression, fatigue, sleep, satisfaction with social roles, pain, and physical function as measured by the PROMIS-43 1 year from registration DNA methylation patterns 3 years
Trial Locations
- Locations (58)
Arizona Cancer Center at University Medical Center North
🇺🇸Tucson, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸Antioch, California, United States
Kaiser Permanente, Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente
🇺🇸Fresno, California, United States
Kaiser Permanente, Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente-Modesto
🇺🇸Modesto, California, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente-Redwood City
🇺🇸Redwood City, California, United States
Kaiser Permanente-Richmond
🇺🇸Richmond, California, United States
Scroll for more (48 remaining)Arizona Cancer Center at University Medical Center North🇺🇸Tucson, Arizona, United States