Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Self-identification as Black or African American (including individuals who are bi-racial but identify themselves as Black or AA)
* Female
* Stage I, II, and III invasive breast carcinoma
* Treatment (surgery, chemotherapy and/or radiation) completed at least 6 months prior to recruitment (ongoing treatment with tamoxifen or AIs is acceptable)
* Age 18 or above at time of diagnosis
* BMI at least 25 km/m2
* Physically able to participate in a moderate physical activity program as assessed by a screening questionnaire and PCP approval.
* Agreeable to random assignment and data collection including blood draw.
* Able to attend twic weekly classes for 6 months.

Exclusion Criteria:

* Plans to move from the community during the study
* Medical condition limiting adherence as assessed by PCP
* History of significant mental illness
* Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study..
* Current/planned use of an FDA-approved or over the counter weight loss medication.
* Participation in another structured weight loss program
B: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to participate in physical activity because of severe disability
C: DISEASE CHARACTERISTICS:

* Diagnosed colorectal, prostate, or female breast cancer

  * At least 5 years beyond date of diagnosis with no clinical evidence of progressive disease or second primaries
* Body mass index ≥ 25 kg/m\^2 and \< 40 kg/m\^2
* Currently exercising \< 150 minutes/week
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:

  * Severe orthopedic condition or scheduled hip or knee replacement within the next 6 months
  * Paralysis
  * End-stage renal disease
  * Dementia
  * Unstable angina
  * Heart attack, congestive heart failure, or pulmonary condition that required oxygen or hospitalization within the past 6 months
* Ability to read, write, and speak English

PRIOR CONCURRENT THERAPY:

* No concurrent warfarin
D: Inclusion Criteria:

* Female
* Cancer diagnosis
* Postmenopausal

Exclusion Criteria:

* Health condition contraindication to moderate physical activity

Answer: B