Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Physical activity and dietary change
- Registration Number
- NCT00811824
- Lead Sponsor
- Columbia University
- Brief Summary
This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
- 21-70 yrs
- Stage 0-IIIa breast cancer
- No evidence of recurrent/metastatic disease
- Hispanic or African descent (African-American or Caribbean)
- BMI > 25kg/m2
- Sedentary
- Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
- Blood pressure < 140/90
- HgbA1C < 8
- LDL cholesterol < 150
- No uncontrolled comorbidities
- VO2 max normal EKG changes
- Non-smoker
- Evidence of recurrent or metastatic breast cancer
- Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
- Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
- Active tobacco use
- Currently active in an exercise and/or dietary change weight loss program
- If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Physical activity and dietary change Immediate physical activity and dietary change intervention 2 Physical activity and dietary change Delayed physical activity and dietary change intervention
- Primary Outcome Measures
Name Time Method Change in weight 6 months, 12 months Intervention adherence 6 months, 12 months
- Secondary Outcome Measures
Name Time Method Barriers to participation 3 months, 6 months, 9 months, 12 months Predictors of adherence 3 months, 6 months, 9 months, 12 months Changes in anthropometric measures 3 months, 6 months, 9 months, 12 months Changes in fitness 3 months, 6 months, 9 months, 12 months Changes in hormonal biomarkers 3 months, 6 months, 9 months, 12 months Changes in metabolic markers 3 months, 6 months, 9 months, 12 months Changes in psychological and quality of life measures 3 months, 6 months, 9 months, 12 months
Trial Locations
- Locations (1)
Columbia University
🇺🇸New York, New York, United States