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Cancer Survival Through Weight Loss and Exercise (CASTLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01217216
First received: October 5, 2010
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer Survivors
 Behavioral: Group-based Intervention
Behavioral: Telephone-based Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Cancer Survival Through Weight Loss and Exercise (CASTLE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Feasibility of recruiting breast cancer survivors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Examination of health outcomes, breast cancer reoccurrence, and mortality. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group-based Intervention
We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.
 Behavioral: Group-based Intervention
compared effects of a group-based intervention on weight loss and physical activity.
Active Comparator: Telephone-based Intervention
We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.
 Behavioral: Telephone-based Intervention
compared telephone-based intervention to weight loss and physical activity.

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217216

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Timothy S Church, MD, MPH, PhD Pennington Biomedica Research Center
Study Director: Donna H Ryan, MD Pennington Biomedical Research Center
Study Director: Conrad P Earnest, PhD Pennington Biomedical Research Center
Study Director: Valerie H Myers, PhD Pennington Biomedical Research Center
Study Director: Catherine M Champagne, PhD Pennington Biomedical Research Center
  More Information

Publications:

Responsible Party: Timothy Church, Principal investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01217216     History of Changes
Other Study ID Numbers: PBRC28036
Study First Received: October 5, 2010
Last Updated: November 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Pennington Biomedical Research Center:
Breast Cancer
Weight loss
Group Intervention
Telephone Intervention

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013