Cancer Survival Through Weight Loss and Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cancer Survival Through Weight Loss and Exercise (CASTLE)

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Behavioral: Group-based Intervention
* Behavioral: Telephone-based Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-based Intervention<br>We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity. | Behavioral: Group-based Intervention<br>* compared effects of a group-based intervention on weight loss and physical activity.<br>|
| Active Comparator: Telephone-based Intervention<br>We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity. | Behavioral: Telephone-based Intervention<br>* compared telephone-based intervention to weight loss and physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruiting breast cancer survivors | To examine the feasibility of recruiting, administering, and maintaining interventions in a small sample of women with a history of breast cancer in a community health setting for pilot data. | 1 year | 
| Examination of health outcomes, breast cancer reoccurrence, and mortality. | To examine health outcomes, cancer reoccurrence, and mortality in women with a history of breast cancer within the 12 month period via adverse events. Additional procedures include resting ECG, waist circumference, weight, and blood work. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Intervention, Breast Cancer, Weight loss, Telephone Intervention