Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Study Overview
=================
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.

Official Title
-----------------
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Physical activity and dietary change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Immediate physical activity and dietary change intervention | Behavioral: Physical activity and dietary change<br>* 6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class<br>|
| Other: 2<br>Delayed physical activity and dietary change intervention | Behavioral: Physical activity and dietary change<br>* 6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | 6 months, 12 months | 
| Intervention adherence |  | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Physical activity, Dietary change