Trial Information

The Survivors' Health And Physical Exercise Study

Background: Overweight or obesity is an established negative prognostic factor in both
premenopausal and postmenopausal breast cancer. Adverse effects of adiposity on prognosis
may be explained by effects on gonadal hormones, insulin, insulin-like growth factor
(IGF)-I, IGF binding proteins (IGFBPs), and leptin.

Objective/Hypothesis: This study tests whether a multifaceted approach can achieve weight
loss and maintenance in overweight or obese breast cancer survivors. The intervention
incorporates cognitive-behavioral therapy, increased physical activity, diet modification,
and strategies to improve body image and self-acceptance. This approach and intervention
were developed and pilot-tested with support from a previous peer-reviewed grant. Weight
change from baseline to one year in the pilot study (n=85) was -5.2 (6.3) kg (mean [SD]) in
the intervention group vs. -0.1 (6.5) kg in the control group (P < 0.05), using intent to
treat analysis with baseline values carried forward for dropouts.

Specific aims: (1) To test whether the intervention promotes weight loss and maintenance of
that loss over an 18-month time period in a larger group; (2) To describe the effect of the
intervention on hormonal factors (insulin, leptin, IGF-I, IGFBP-1, IGFBP-3, sex-hormone
binding globulin, and serum estrogens); and (3) To describe the relationships between body
weight and weight reduction and measures of psychosocial factors (health-related quality of
life, fatigue, depression, eating attitudes, and weight and shape concerns).

Study design: The study targets 253 overweight or obese women previously treated for early
stage breast cancer and utilizes a randomized study design with subjects assigned to the
group-based healthy weight management program (with individualized telephone counseling
support) or a wait-list control group. Data collection includes anthropometric and
psychosocial measures, body composition (dual-energy x-ray absorptiometry), cardiopulmonary
fitness testing, and hormonal measures at baseline and six and 18 months.