Breast Cancer Clinical Trial
Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors
Summary
This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.
Full Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.
II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.
III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.
OUTLINE:
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
After completion of study, patients are followed up at 3 and 6 months.
Eligibility Criteria
Inclusion Criteria:
Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
Overweight/obese (body mass index [BMI] > 25).
Ability to understand and the willingness to sign a written informed consent.
Willing and physically able to participate in physical activity.
Obtain physician consent via primary care physician and/or treating oncologist.
Exclusion Criteria:
> 60 months post breast cancer therapy.
Contraindications to exercise.
Diagnosis of cancer other than breast that is receiving active treatment.
Currently receiving chemotherapy/radiation.
Musculoskeletal/neurological disorder inhibiting them from safe exercise.
Pregnant or nursing women.
Unable to give informed consent.
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There is 1 Location for this study
Columbus Ohio, 43210, United States More Info
Principal Investigator
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