Cancer Survival Through Weight Loss and Exercise (CASTLE)
30 Years
75 Years
Female
Breast Cancer Survivors
Trial Information
Cancer Survival Through Weight Loss and Exercise (CASTLE)
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Weight loss
Outcome Description:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Timothy S Church, MD, MPH, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Pennington Biomedica Research Center
Authority:
United States: Federal Government
Study ID:
PBRC28036
NCT ID:
NCT01217216
Start Date:
May 2009
Completion Date:
October 2010
Related Keywords:
- Breast Cancer Survivors
- Breast Cancer
- Weight loss
- Group Intervention
- Telephone Intervention
- Breast Neoplasms
- Weight Loss
Name | Location |
|---|---|
| Pennington Biomedical Research Center | Baton Rouge, Louisiana 70808 |
