A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity

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.

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.

Inclusion Criteria:

- Have a previous history of invasive breast cancer who have completed treatment, except
for hormonal therapy.

- Report less than 150 minutes of moderate physical activity weekly. Moderate physical
activity would be activity of an intensity that you could talk during the activity,
but not sing, and might be enough to break a sweat (e.g., brisk walk, yoga, shooting
hoops, leisurely bicycling, dancing, leisurely swimming or treading water, gardening,
or housework like sweeping).

- 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:

- 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.