A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
NCT ID: NCT03789877
Last Updated: 2021-10-26
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-01-16
2021-02-05
Brief Summary
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Detailed Description
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I. To examine the effects of 20 hertz (Hz) repetitive transcranial magnetic stimulation (rTMS) on delay discounting rates and multiple measures of self-regulation and walking.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.
GROUP II: Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group I (home-based walking program, rTMS)
Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.
Physical Activity
Participate in home-based walking program
Questionnaire Administration
Ancillary studies
Repetitive Transcranial Magnetic Stimulation
Undergo rTMS
Group II (home-based exercise program, sham rTMS)
Patients participate in a home-based exercise program of at least 10,000 steps per day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12 weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour for 8 sessions during the first 2 weeks of the walking program.
Physical Activity
Participate in home-based walking program
Questionnaire Administration
Ancillary studies
Sham Intervention
Undergo sham rTMS
Interventions
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Physical Activity
Participate in home-based walking program
Questionnaire Administration
Ancillary studies
Repetitive Transcranial Magnetic Stimulation
Undergo rTMS
Sham Intervention
Undergo sham rTMS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Approved by a participant's physician to participate in this study.
* Have a smart phone or tablet with the capability of downloading the Fitbit activity tracker application, and a willingness to sync Fitbit activity tracker data with the application daily.
* Right handed.
* Pass the Transcranial Magnetic Stimulation Adult Safety and Screening questionnaire (TASS).
* Ability to speak and read English.
Exclusion Criteria
* Have metastatic breast cancer.
* Morbidly obese as defined by a body mass index (BMI) \>= 40.
* Have any condition which would preclude receiving rTMS, including:
* Personal history of epilepsy, head injury, aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurysm, etc.)
* A self-reported diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus.
* Metal implants or neuro-stimulators in the head, neck, or cochlea.
* A pacemaker.
* Known pre-existing noise induced hearing loss or concurrent treatment with ototoxic medications (i.e., aminoglycosides, cisplatin).
* Use of anticonvulsant medication, or currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion).
* Participants who score above 48.3 on the Claustrophobia questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo an Magnetic Resonance Imaging (MRI) without distress.
* Unwilling or unable to follow protocol requirements.
* Any condition which the principal investigator determines will make the participant an unsuitable candidate to participate in the study.
18 Years
64 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Christine Sheffer
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2018-03302
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 72218
Identifier Type: OTHER
Identifier Source: secondary_id
I 72218
Identifier Type: -
Identifier Source: org_study_id