Back to resultsA Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
Primary Purpose
Cancer Survivor, Invasive Breast Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Questionnaire Administration
Repetitive Transcranial Magnetic Stimulation
Sham Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Survivor
Eligibility 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.
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I (home-based walking program, rTMS)
Group II (home-based exercise program, sham rTMS)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Delay discounting score
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.
Number of steps per day
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.
Number of minutes of moderate physical activity per day
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03789877
First Posted
December 26, 2018
Last Updated
October 22, 2021
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03789877
Brief Title
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
Official Title
Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Invasive Breast Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (home-based walking program, rTMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (home-based exercise program, sham rTMS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
Participate in home-based walking program
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS
Intervention Description
Undergo rTMS
Intervention Type
Procedure
Intervention Name(s)
Sham Intervention
Intervention Description
Undergo sham rTMS
Primary Outcome Measure Information:
Title
Delay discounting score
Description
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.
Time Frame
Baseline up to 6 months
Title
Number of steps per day
Description
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.
Time Frame
Baseline up to 6 months
Title
Number of minutes of moderate physical activity per day
Description
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.
Time Frame
Baseline up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Sheffer
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
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