Cancer Survival Through Weight Loss and Exercise (CASTLE)

Cancer Survival Through Weight Loss and Exercise (CASTLE)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Behavioral: Group-based Intervention; Behavioral: Telephone-based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Weight loss; Group Intervention; Telephone Intervention
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PBRC 28036