This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study plan for 1 year. If there is successful enrollment in this study, the plan is to use what is learned in this study to design a larger, longer-term clinical trial to look at the effect of weight loss and incidence of cancer recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
Standard of care bariatric surgery with sleeve gastrectomy
All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
Feasibility of Weight Loss Intervention
Feasibility for women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but \< 50 kg/m2.
Time frame: 1 Year
Acceptability of Weight Loss Intervention
Acceptability of women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but \< 50 kg/m2.
Time frame: 1 Year
Weight Loss
Percent body mass weight loss
Time frame: 1 Year
Breast Cancer Recurrence
Incidence of breast cancer recurrence
Time frame: 1 Year
Cancer Related Mortality
Incidence of cancer related mortality
Time frame: 1 Year
Overall Mortality
Incidence of overall mortality
Time frame: 1 Year
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