Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-04-26
2027-12-31
Brief Summary
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Detailed Description
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Primary Objective To compare the effect of a 16-week multimodality, virtually delivered exercise intervention on cardiorespiratory fitness measured by a modified Bruce ramp protocol treadmill test to usual care, in patients with indolent metastatic breast cancer.
Secondary Objectives
1. To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP)
2. To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire
3. To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on CT scans obtained as standard of care using SliceOmatic software
4. To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear
5. To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29)
6. To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire
7. To describe patient uptake and adherence with the intervention, measured by proportion of approached patients who consent to the study, and proportion of assigned training sessions attended by patients randomized to the exercise arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise Intervention
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Exercise Intervention
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Usual Care
Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.
No interventions assigned to this group
Interventions
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Exercise Intervention
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of metastatic breast cancer
3. No progression of disease in the 12 months prior to screening per the treating investigator
1. If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
2. Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
4. ECOG performance status of 0-2
5. Ability to walk on a treadmill without assistive device.
6. Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
7. Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the IPAQ questionnaire administered during screening)
8. Participants should have a cellular device compatible with iOS 15 or Android operating system 7.
Exclusion Criteria
1. Participants receiving endocrine therapy are eligible.
2. Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
2. Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supersede this eligibility criteria.
* NYHA class III or IV congestive heart failure
* Uncontrolled angina
* Myocardial infarction in the prior 12 months
* Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
* Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms \> 2 days/week) or dyspnea requiring oxygen
* Symptomatic peripheral vascular disease
* Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness
* History of fragility fracture
3. Active, untreated brain metastases
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Tarah J Ballinger, MD
Assistant Professor of Clinical Medicine
Principal Investigators
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Tarah Ballinger, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
IU Health West
Avon, Indiana, United States
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, United States
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Cancilla MA, Nemati D, Halsey D, Shah N, Sherman M, Kelly N, Zhang P, Kassem N, Kaushal N, Shanahan K, Glenn LK, Ligibel JA, Ballinger TJ. Exercise as part of survivorship care in metastatic breast cancer: protocol for the randomized EMBody trial. BMC Cancer. 2024 Sep 12;24(1):1137. doi: 10.1186/s12885-024-12883-6.
Other Identifiers
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CTO-IUSCCC-0781
Identifier Type: -
Identifier Source: org_study_id
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