Cancer Survival Through Weight Loss and Exercise (CASTLE)
Primary Purpose
Breast Cancer Survivors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group-based Intervention
Telephone-based Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Survivors focused on measuring Breast Cancer, Weight loss, Group Intervention, Telephone Intervention
Eligibility 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.
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group-based Intervention
Telephone-based Intervention
Arm Description
We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.
We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01217216
First Posted
October 5, 2010
Last Updated
September 13, 2022
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01217216
Brief Title
Cancer Survival Through Weight Loss and Exercise
Acronym
CASTLE
Official Title
Cancer Survival Through Weight Loss and Exercise (CASTLE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors
Keywords
Breast Cancer, Weight loss, Group Intervention, Telephone Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-based Intervention
Arm Type
Active Comparator
Arm Description
We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.
Arm Title
Telephone-based Intervention
Arm Type
Active Comparator
Arm Description
We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Group-based Intervention
Intervention Description
compared effects of a group-based intervention on weight loss and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based Intervention
Intervention Description
compared telephone-based intervention to weight loss and physical activity.
Primary Outcome Measure Information:
Title
Weight loss
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Feasibility of recruiting breast cancer survivors
Description
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.
Time Frame
1 year
Title
Examination of health outcomes, breast cancer reoccurrence, and mortality.
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedica Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donna H Ryan, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Conrad P Earnest, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Valerie H Myers, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine M Champagne, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22535636
Citation
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.
Results Reference
result
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Cancer Survival Through Weight Loss and Exercise
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