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Exercise Program for Breast Cancer Survivors
N/A
Waitlist Available
Led By Karen Basen-Engquist, PHD, BA, MPH
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be Female and be 21 years of age or older. (Pilot Test and PreTest Criteria)
History of breast cancer (invasive or ductal carcinoma in situ). (Pilot Test Criteria only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing an exercise program for Hispanic breast cancer survivors to see what the most effective strategies are for promoting exercise.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves an exercise program rather than medication, side effects may include typical responses to new physical activities such as muscle soreness or fatigue. Serious risks are minimized by excluding those with certain health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 21 or older.
Select...
I have a history of breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Exercise Behavior and Energy Expenditure
Secondary outcome measures
Effects of Behavioral Exercise Intervention on Biological Markers
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Written Materials
2010
N/A
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,614 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,307 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,749 Total Patients Enrolled
147 Trials studying Breast Cancer
63,233 Patients Enrolled for Breast Cancer
Karen Basen-Engquist, PHD, BA, MPHPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
550 Total Patients Enrolled
1 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am aware of who I am, where I am, and the current time.I am a woman aged 21 or older.You do not engage in the amount of physical activity that is recommended by health experts.I have a history of breast cancer.I finished my cancer treatment (surgery, chemo, or radiation) over 3 months ago.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.
Research Study Groups:
This trial has the following groups:- Group 1: Cultural Related Material Group
- Group 2: Waitlist Group
- Group 3: Non-Cultural Related Material Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently seeking out new participants?
"According to clinicaltrials.gov, this trial is not actively seeking participants at present. It was first posted on February 7th 2012 and last modified on October 11th 2022. Nevertheless, there are a multitude of medical studies looking for volunteers with 2602 trials now open for recruitment."
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