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Cancer Survival Through Weight Loss and Exercise (CASTLE)


N/A
30 Years
75 Years
Not Enrolling
Female
Breast Cancer Survivors

Thank you

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 CenterBaton Rouge, Louisiana  70808