Trials / Completed

CompletedNCT01453452

S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 50 (actual)

Sponsor: SWOG Cancer Research Network · Network
Sex: Female
Age: 120 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	behavioral dietary intervention	Reduce caloric intake by 500 kcal/day, increase fruit and vegetable intake to 5 or more servings per day, and limit daily calories from fat to be \< 30%. Diet will be measured using 3 repeated 24-hr diet recalls. Participants will receive information on the recommended dietary modifications via mailed materials and telephone counseling sessions.
BEHAVIORAL	exercise intervention	150 min/wk of moderate exercise through use of the Curves® centers, engage in physical activity outside of Curves®, and use pedometers to track activity.
OTHER	counseling intervention	14 40-min behavioral counseling sessions via telephone with the goal of increasing intervention adherence and increasing participant retention.
PROCEDURE	quality-of-life assessment	PROMIS-43 - online questionnaire to assess quality of life.

Timeline

Start date: 2012-03-01
Primary completion: 2015-08-01
Completion: 2017-01-01
First posted: 2011-10-17
Last updated: 2020-01-18

Locations

58 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01453452. Inclusion in this directory is not an endorsement.