Cancer SurvivorNCT03789877
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
A study testing Physical Activity, Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation in people with Cancer Survivor and Invasive Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cancer Survivor, Invasive Breast Carcinoma
- What is being tested?
- Physical Activity, Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Cancer Survivor, Invasive Breast Carcinoma
- Being tested
- Physical Activity, Questionnaire Administration, Repetitive Transcranial Magnetic Stimulation, Sham Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
Participate in home-based walking program
Questionnaire AdministrationOther
Ancillary studies
Repetitive Transcranial Magnetic StimulationProcedure or surgery
Also called rTMS
Undergo rTMS
Sham InterventionProcedure or surgery
Undergo sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| Group I (home-based walking program, rTMS) | Experimental | 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. Receives: Other: Physical Activity; Other: Questionnaire Administration; Procedure: Repetitive Transcranial Magnetic Stimulation |
| Group II (home-based exercise program, sham rTMS) | Active comparator | 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. Receives: Other: Physical Activity; Other: Questionnaire Administration; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6 months
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.
Measured: Baseline up to 6 months
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.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start16 Jan 2019
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Sheffer, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789877
- Sponsor's protocol ID
- I 72218
- Other IDs
- NCI-2018-03302, I 72218
- Status last verified
- Oct 2021
- First submitted
- 26 Dec 2018
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing
- ClinicalTrials.gov ID
- NCT03789877
- Acronym / sponsor ID
- I 72218
- Conditions
- Cancer Survivor, Invasive Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (home-based walking program, rTMS) | Experimental | Other: Physical Activity, Other: Questionnaire Administration, Procedure: Repetitive Transcranial Magnetic StimulationPatients 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 (home-based exercise program, sham rTMS) | Active comparator | Other: Physical Activity, Other: Questionnaire Administration, Procedure: Sham InterventionPatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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:
- Unwilling or unable to follow protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityParticipate in home-based walking program | Other | Group I (home-based walking program, rTMS), Group II (home-based exercise program, sham rTMS) |
| Questionnaire AdministrationAncillary studies | Other | Group I (home-based walking program, rTMS), Group II (home-based exercise program, sham rTMS) |
| Repetitive Transcranial Magnetic StimulationAlso: rTMSUndergo rTMS | Procedure or surgery | Group I (home-based walking program, rTMS) |
| Sham InterventionUndergo sham rTMS | Procedure or surgery | Group II (home-based exercise program, sham rTMS) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Sheffer principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity, Questionnaire Administration and Repetitive Transcranial Magnetic Stimulation in people with Cancer Survivor and Invasive Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay discounting score (time frame: Baseline up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.