Breast Cancer Clinical Trial
Lifestyle, Exercise and Nutrition Study 2 (LEAN 2)
Summary
The specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, serum hormones, and breast tissue markers associated with prognosis in breast cancer survivors.
Full Description
We will conduct a two-armed study comparing a combination of an in-person and telephone weight loss program compared to usual care/wait list in 100 breast cancer survivors. Women will be randomized into one of the study arms using a random permuted block design. Research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.
Eligibility Criteria
Inclusion Criteria:
American Joint Committee on Cancer (AJCC) Stages 0-IIIC Breast Cancer
BMI >25 kg/m2
Completed surgery, chemotherapy and radiation at least 2 months ago
Physically able to exercise
Agrees to be randomly assigned to either weight loss or control
Gives informed consent to participate in all study activities
Able to come for baseline and 6-month clinic visits
Mentally competent
Exclusion Criteria:
Patients with double mastectomy
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There is 1 Location for this study
New Haven Connecticut, 06519, United States
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