Lifestyle, Exercise and Nutrition Study 2 (LEAN 2) (LEAN 2)
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:
- Patients with double mastectomy
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
In-Person or Telephone-Based Counseling
Usual Care/Wait List
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.
At 6-months the participants in the Wait List group may choose to participate in the 11 sessions either in-person or via telephone or a combination of the two modes of delivery. They will also be offered the opportunity to return to Yale at 12-months (immediately after the end of the 6-month counseling sessions) to have weight and DEXA measured.