Weight Reduction Intervention for Breast Cancer Survivors
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse effect of excess body fat on prognosis following the diagnosis of breast cancer, including increased circulating sex hormones, insulin, leptin, and various growth factors. Results from previous studies suggest that specific strategies can facilitate weight reduction and maintenance of weight loss in this target population. This randomized clinical trial will recruit 253 overweight or obese women who have been previously treated for early stage breast cancer and will test whether a multifaceted approach to promoting healthy weight management can achieve the goal of weight loss and maintenance. Additionally, this study tests whether weight loss is associated with changes in biological and psychosocial factors, including eating attitudes and behaviors and health-related quality of life. The intervention incorporates cognitive-behavioral therapy, increased physical activity, diet modification to facilitate a modest reduction in energy intake, and strategies to improve body image and self-acceptance. This approach and intervention have been pilot-tested with breast cancer survivors in a developmental project, which resulted in the intervention group losing significantly more weight than the wait-list control group. Study Aims include: testing whether an intervention that emphasizes increased physical activity and individualized diet modification to promote an energy imbalance is associated with a greater degree of weight loss and maintenance of that loss over an 18-month time period; describing the effect of the intervention on hormones and growth factors; describing the relationships between body weight and weight reduction and measures of selected psychosocial factors. Measurements of hormonal and psychosocial factors in this study will provide insight into the responsiveness of these factors to weight loss in overweight or obese breast cancer survivors, which will provide an indication of the degree of clinical benefit that is achieved with the intervention efforts. Results from this study may enable the development of broader efforts transferable to clinical practice and public health, and thus, may ultimately have a substantial effect on the risk for recurrence and long-term survival of the estimated 1.98 million breast cancer survivors in the U.S. today.
Key facts
- Study ID
- NCT00774371
- Run by
- University of California, San Diego
- People needed
- 253
- Starts
- 2005-01-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2023-11-30
Who can join
Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with Stage I-IIIA breast cancer within the previous 10 years
- Have completed initial treatments (i.e., surgery, adjuvant chemotherapy, radiation therapy)
- Have initial BMI >25.0 kg/m2
- A minimum of 15 kg over ideal weight
- Willingness and ability to attend group meetings and to maintain contact with the investigators for 18 months
- Ability to provide dietary and exercise data by telephone at prescribed intervals.
You may not qualify if…
- Inability to participate in physical activity because of severe disability
Where it is running
- Moores UCSD Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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