Breast Cancer Clinical Trial

Exercise in Improving Health and Quality of Life in Breast Cancer Survivors

Summary

This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.

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Full Description

PRIMARY OBJECTIVE:

I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors.

SECONDARY OBJECTIVE:

I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm.

OUTLINE: Participants are randomized into 1 of 5 arms.

ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also undergo resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands.

ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants undergo resistance training as in Arm I.

ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training (HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance training as in Arm I.

ARM IV: Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I.

ARM V: Participants wear Fitbit and continue their usual physical activity over 12 weeks.

After completion of study intervention, participants are followed up at 2 weeks and 1 month.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa)
Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise)
Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM)

Exclusion Criteria:

Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Are pregnant or nursing
Are unwilling or unable to follow protocol requirements
Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
Have metastatic breast cancer
Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise

Study is for people with:

Breast Cancer

Estimated Enrollment:

190

Study ID:

NCT03679559

Recruitment Status:

Recruiting

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Tracey L. O'Connor
Contact
716-845-1486
[email protected]
Tracey L. O'Connor
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

190

Study ID:

NCT03679559

Recruitment Status:

Recruiting

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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