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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

No Placebo-Only Group

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.

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.

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 below

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I am a woman aged 21 or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Exercise Behavior and Energy Expenditure

Secondary study objectives

Effects of Behavioral Exercise Intervention on Biological Markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

Written Materials

2010

N/A

~1190

Questionnaires

2013

Completed Phase 2

~4280