S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
- 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.
- 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
- 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
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Attendance of ≥ 2 Curves sessions/week for a minimum of 36 of the 52 weeks of intervention
1 year from registration
Heather Greenlee, PhD, ND
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Columbia University||New York, New York 10032-3784|