Status:
COMPLETED
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Cancer Survivor
Invasive Breast Carcinoma
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This trial studies how well a home-based walking program, with or without repetitive transcranial magnetic stimulation, works in helping breast cancer survivors get more physical activity. Physical ac...
Detailed Description
PRIMARY OBJECTIVES: 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. OU...
Eligibility Criteria
Inclusion
- Have a previous history of invasive breast cancer who have completed treatment, except for hormonal therapy.
- 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
- Pregnant or nursing.
- 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.
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03789877
Start Date
January 16 2019
End Date
February 5 2021
Last Update
October 26 2021
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263