Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial
2 other identifiers
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2017
CompletedFirst Submitted
Initial submission to the registry
September 18, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2022
CompletedSeptember 1, 2023
August 1, 2023
4.7 years
September 18, 2018
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of randomized patients who are still on study at the end of the 12 week intervention
The feasibility outcomes will be assessed by a multivariable logistic regression model for the relative odds of remaining on the study (ref: not). Each of the active treatment arms will be compared to the control. The model will be supported by the randomized patient set, counting patients who withdraw from the study as feasibility failures. No variable selection steps will be taken; inferences will be based on the estimates and 95% confidence intervals from the full model. Optimism adjusted odds ratio estimates will also be reported, to better inform design of future studies.
At 12 weeks
Secondary Outcomes (1)
Adherence rate in each of the active intervention arms
Up to 12 weeks
Other Outcomes (6)
Cardiovascular fitness
At baseline and 12 weeks
Body composition
At baseline and 12 weeks
Quality of life
At baseline and 12 weeks
- +3 more other outcomes
Study Arms (5)
Arm I (home-based walking program, resistance training)
EXPERIMENTALParticipants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and brisk walk 30 minutes per day 5 days a week in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also receive 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 (home-based Zumba program, resistance training)
EXPERIMENTALParticipants 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 receive resistance training as in Arm I.
Arm III (HIIT, resistance training)
EXPERIMENTALParticipants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Arm IV (supervised moderate intensity walking program)
ACTIVE COMPARATORParticipants 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 (usual physical activity)
ACTIVE COMPARATORParticipants wear Fitbit and continue their usual physical activity over 12 weeks.
Interventions
Continue usual physical activity
Complete home-based walking program and resistance training
Complete home-based Zumba program and resistance training
Complete HIIT program and resistance training
Watch video
Correlative studies
Wear Fitbit
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellis Levine
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2018
First Posted
September 20, 2018
Study Start
October 6, 2017
Primary Completion
June 2, 2022
Study Completion
June 2, 2022
Last Updated
September 1, 2023
Record last verified: 2023-08