Trial Summary
What is the purpose of this trial?
The goal of this research study is to test an exercise program that is designed for Hispanic breast cancer survivors. Researchers want to learn the most effective strategies for promoting exercise.
Research Team
Karen M. Basen-Engquist
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for Hispanic female breast cancer survivors over 21 years old, who are not currently meeting physical activity guidelines and are at least 3 months post treatment. They must be able to consent, read/write in English or Spanish, and live in Harris County, Texas or nearby areas. Those on Herceptin or with conditions that make exercise dangerous can't join.Inclusion Criteria
Be able to provide informed consent. (Pilot Test and PreTest Criteria)
I am aware of who I am, where I am, and the current time.
I am a woman aged 21 or older.
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Exclusion Criteria
I am currently on Herceptin or non-hormonal cancer treatment.
You have recently experienced a heart attack, unstable angina, uncontrolled heart rhythm issues, severe aortic stenosis, uncontrolled heart failure, acute pulmonary embolism or infarction, acute myocarditis or pericarditis, or acute systemic infection with fever and body aches.
Treatment Details
Interventions
- Baseline Fitness Test (Behavioral Intervention)
- Individualized Exercise Program (Behavioral Intervention)
- Questionnaires (Behavioral Intervention)
- Written Materials (Behavioral Intervention)
Trial OverviewThe study tests an individualized exercise program tailored for Hispanic breast cancer survivors. It includes a baseline fitness test, questionnaires to track progress, and educational materials aimed at promoting regular exercise habits.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Non-Cultural Related Material GroupExperimental Treatment4 Interventions
Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.
Group II: Cultural Related Material GroupExperimental Treatment4 Interventions
Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.
Group III: Waitlist GroupActive Control2 Interventions
Patients may choose to participate in the exercise program after 16-week assessment. After 4 months of exercise, all the follow-up tests repeated. Exercise recommendation then given, and all of the intervention materials.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3107
Patients Recruited
1,813,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+