Breast Cancer Clinical Trial
A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors
Summary
Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).
Full Description
The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.
The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.
Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.
Eligibility Criteria
Inclusion Criteria:
Overweight individuals (BMI >= 25.0 kg/m2)
Breast cancer survivors who have completed chemotherapy and/or radiation therapy
Stage 0-III
The ability to be physically able to exercise (e.g. walk at a moderate pace)
Agree to random assignment to either group
Give informed consent to participate in all study activities
Accessible by telephone
Able read and communicate in English
Exclusion Criteria:
Pregnant or intending to become pregnant in the next year
Recent (past 6 months) stroke or myocardial infarction
Severe uncontrolled mental illness
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There is 1 Location for this study
New Haven Connecticut, 06511, United States
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