Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Survivors' Health And Physical Exercise Study
Brief Summary: 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.


Options:
A: Arm Label: Shape-Up following cancer treatment; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Shape-Up following cancer treatment | Arm Label: Control intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Shape-Up following cancer treatment; Assigned to Arm(s): Shape-Up following cancer treatment
B: Arm Label: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: behavioral dietary intervention, Other: counseling intervention, Other: educational intervention, Other: preventative dietary intervention, Procedure: quality-of-life assessment | Arm Label: Without Counseling; Type: ACTIVE_COMPARATOR; Interventions: Procedure: quality-of-life assessment | Intervention Type: BEHAVIORAL; Name: behavioral dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: counseling intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: educational intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: OTHER; Name: preventative dietary intervention; Assigned to Arm(s): Lifestyle counseling | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Lifestyle counseling, Without Counseling
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive behavioral therapy CBT) for weight loss | Intervention Type: BEHAVIORAL; Name: Cognitive behavioral therapy CBT) for weight loss; Assigned to Arm(s): 1
D: Arm Label: Wait-list control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Lifestyle counseling; Type: EXPERIMENTAL; Interventions: Behavioral: behavioral dietary and exercise intervention | Intervention Type: BEHAVIORAL; Name: behavioral dietary and exercise intervention; Assigned to Arm(s): Lifestyle counseling

Answer: C