Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Cancer Survival Through Weight Loss and Exercise

Summary: To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.

Detailed description: This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.

Eligibility: Inclusion Criteria:
  -  Women between the ages of 30 and 75.
  -  Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization.
  -  BMI ≥ 25 kg/m2 and ≤ 45 kg/m2
  -  Not involved in regular physical activity or weight loss management programs.
  -  Stage I, II or IIIa breast cancer with good prognosis.
  Exclusion Criteria:
  -  Presence of any co-morbidities including cardiovascular disease or diabetes
  -  Fasting triglycerides > 500 mg/dl.
  -  Consume more than 14 alcoholic beverages per week.
  -  A history of drug abuse, or excess alcohol consumption (40g/day)6.
  -  Currently dieting or engaging in any activity with the goal of losing weight.
  -  Significant intentional weight loss in the past year (> 50 lbs in the past year) or current use of weight loss medications.
  -  History of gastrointestinal bypass or other bariatric surgery in the last 3 years.
  -  Pregnant or plan on becoming pregnant in the next 12 months.
  -  Factors that may limit adherence to intervention or affect conduct of the trial.
  -  Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
  -  Failure to complete run-in and baseline testing.
  -  Lack support from health care provider or family members.
  -  Other temporary intervening event, such as sick spouse, bereavement, or recent move.
  -  Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
  -  Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
  -  Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.

Relevance to patient case: not relevant