Lifestyle, Exercise and Nutrition Study 1 (LEAN)
Breast Cancer, Weight Loss
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Survivorship, Weight Loss
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:
-
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
No Intervention
In-Person Counseling
Telephone-based Counseling
Usual Care
Participants randomized to in-person counseling will meet via in-person or via telephone (but at least 3 of the 11 sessions must be in person) weekly for month 1, then every other week for months 2, and 3, and then monthly for months 4-6 at Yale University. The meetings will last 30 minutes. Participants will turn in their diet and exercise logs and also be weighed. A lesson will then be discussed (see above for content).
The exact same information, content, schedule, and 30 minute sessions will be provided to telephone-based participants as offered to participants who receive in-person counseling. Participants will be taught diet, exercise and behavior change strategies via the telephone (weekly calls for month 1, every other week for months 2-3, and monthly for months 4-6). All lessons and diet and physical activity logs will be mailed to them at the beginning of the program. Participants will record their daily diet and exercise in the logs. Every four weeks, participants will return, via stamped, addressed envelopes, the logs to the study office.
Immediately after randomization, participants in the Usual Care Group will be provided written information that emphasizes the importance of a healthy lifestyle. Usual care participants will be encouraged to follow the American Cancer Society (ACS) nutrition and physical activity guidelines. Upon completion of the study (at 6 months), usual care participants will be offered all the educational material, as well as an in-person or telephone counseling session.