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

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ClinicalTrials.gov Identifier: NCT03789877
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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 activity has been shown to improve health outcomes and quality of life among breast cancer survivors and can help lessen certain side effects of treatment such as fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS with a home-based walking program may help breast cancer survivors get more physical activity.

Condition or disease Intervention/treatment Phase
Cancer Survivor Invasive Breast Carcinoma Other: Physical Activity Other: Questionnaire Administration Procedure: Repetitive Transcranial Magnetic Stimulation Procedure: Sham Intervention Not Applicable

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : November 13, 2019
Estimated Study Completion Date : September 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Physical Activity
Participate in home-based walking program

Other: Questionnaire Administration
Ancillary studies

Procedure: Repetitive Transcranial Magnetic Stimulation
Undergo rTMS
Other Name: rTMS

Active Comparator: 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.
Other: Physical Activity
Participate in home-based walking program

Other: Questionnaire Administration
Ancillary studies

Procedure: Sham Intervention
Undergo sham rTMS




Primary Outcome Measures :
  1. Delay discounting score [ Time Frame: Baseline up to 6 months ]
    The effect of the transcranial magnetic stimulation (TMS) intervention on the delay discounting score will be assessed using a two-arm, randomized, double-blind, sham controlled repeated measures design. The efficacy of TMS will be quantified by comparing the within-patient change in delay discounts scores between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model, describing the continuous delay discounting outcomes as a function of a random participant effect, and fixed effects for treatment assignment (TMS reference: sham), categorical visit number (4 levels), and the treatment/visit interaction. The magnitude, direction and 95% confidence interval for the adjusted interaction term estimate will be used to describe the effect of TMS on the delay discounting score. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate.

  2. Number of steps per day [ Time Frame: Baseline up to 6 months ]
    The effects of TMS on steps per day will be quantified by comparing the within-patient change in these outcomes between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model as described above. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate. This analysis will be used to determine the feasibility of using rTMS to enhance a home-based walking intervention among breast cancer survivors, based on whether breast cancer survivors who receive active rTMS demonstrate more steps per day than breast cancer survivors who receive sham rTMS.

  3. Number of minutes of moderate physical activity per day [ Time Frame: Baseline up to 6 months ]
    The effects of TMS on minutes of activity per week will be quantified by comparing the within-patient change in these outcomes between the baseline and week 12 assessments in the evaluable sample. The treatment effect will be estimated with a generalized linear mixed model as described above. These results will be supported by descriptive statistics and graphical depictions of the results as appropriate. This analysis will be used to determine the feasibility of using rTMS to enhance a home-based walking intervention among breast cancer survivors, based on whether breast cancer survivors who receive active rTMS demonstrate more minutes of moderate intensity activity than breast cancer survivors who receive sham rTMS.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789877


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Christine Sheffer    716-845-1186    Christine.Sheffer@roswellpark.org   
Principal Investigator: Christine Sheffer         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christine Sheffer Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03789877     History of Changes
Other Study ID Numbers: I 72218
NCI-2018-03302 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 72218 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases