<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789877</url>
  </required_header>
  <id_info>
    <org_study_id>I 72218</org_study_id>
    <secondary_id>NCI-2018-03302</secondary_id>
    <secondary_id>I 72218</secondary_id>
    <nct_id>NCT03789877</nct_id>
  </id_info>
  <brief_title>A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity</brief_title>
  <official_title>Enhancing A Home-Based Walking Intervention Among Breast Cancer Survivors With rTMS: Feasibility and Limited Efficacy Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well a home-based walking program, with or without repetitive&#xD;
      transcranial magnetic stimulation, works in helping breast cancer survivors get more physical&#xD;
      activity. Physical activity has been shown to improve health outcomes and quality of life&#xD;
      among breast cancer survivors and can help lessen certain side effects of treatment such as&#xD;
      fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic&#xD;
      stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS&#xD;
      with a home-based walking program may help breast cancer survivors get more physical&#xD;
      activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To examine the effects of 20 hertz (Hz) repetitive transcranial magnetic stimulation&#xD;
      (rTMS) on delay discounting rates and multiple measures of self-regulation and walking.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients participate in a home-based exercise program of at least 10,000 steps per&#xD;
      day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12&#xD;
      weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8&#xD;
      sessions during the first 2 weeks of the walking program.&#xD;
&#xD;
      GROUP II: Patients participate in a home-based exercise program of at least 10,000 steps per&#xD;
      day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12&#xD;
      weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour&#xD;
      for 8 sessions during the first 2 weeks of the walking program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">February 5, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delay discounting score</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of steps per day</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of minutes of moderate physical activity per day</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>Invasive Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group I (home-based walking program, rTMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (home-based exercise program, sham rTMS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>Participate in home-based walking program</description>
    <arm_group_label>Group I (home-based walking program, rTMS)</arm_group_label>
    <arm_group_label>Group II (home-based exercise program, sham rTMS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (home-based walking program, rTMS)</arm_group_label>
    <arm_group_label>Group II (home-based exercise program, sham rTMS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation</intervention_name>
    <description>Undergo rTMS</description>
    <arm_group_label>Group I (home-based walking program, rTMS)</arm_group_label>
    <other_name>rTMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Intervention</intervention_name>
    <description>Undergo sham rTMS</description>
    <arm_group_label>Group II (home-based exercise program, sham rTMS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a previous history of invasive breast cancer who have completed treatment, except&#xD;
             for hormonal therapy.&#xD;
&#xD;
          -  Approved by a participant's physician to participate in this study.&#xD;
&#xD;
          -  Have a smart phone or tablet with the capability of downloading the Fitbit activity&#xD;
             tracker application, and a willingness to sync Fitbit activity tracker data with the&#xD;
             application daily.&#xD;
&#xD;
          -  Right handed.&#xD;
&#xD;
          -  Pass the Transcranial Magnetic Stimulation Adult Safety and Screening questionnaire&#xD;
             (TASS).&#xD;
&#xD;
          -  Ability to speak and read English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Have metastatic breast cancer.&#xD;
&#xD;
          -  Morbidly obese as defined by a body mass index (BMI) &gt;= 40.&#xD;
&#xD;
          -  Have any condition which would preclude receiving rTMS, including:&#xD;
&#xD;
               -  Personal history of epilepsy, head injury, aneurysm, stroke, or previous cranial&#xD;
                  neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurysm, etc.)&#xD;
&#xD;
               -  A self-reported diagnosis of major depressive disorder, bipolar disorder or a&#xD;
                  schizophrenia-spectrum disorder, or tinnitus.&#xD;
&#xD;
               -  Metal implants or neuro-stimulators in the head, neck, or cochlea.&#xD;
&#xD;
               -  A pacemaker.&#xD;
&#xD;
               -  Known pre-existing noise induced hearing loss or concurrent treatment with&#xD;
                  ototoxic medications (i.e., aminoglycosides, cisplatin).&#xD;
&#xD;
               -  Use of anticonvulsant medication, or currently taking medications that lower&#xD;
                  seizure threshold (e.g., such as tricyclic antidepressants or bupropion).&#xD;
&#xD;
               -  Participants who score above 48.3 on the Claustrophobia questionnaire at the&#xD;
                  baseline assessment will be excluded because they are likely to be unable to&#xD;
                  undergo an Magnetic Resonance Imaging (MRI) without distress.&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements.&#xD;
&#xD;
          -  Any condition which the principal investigator determines will make the participant an&#xD;
             unsuitable candidate to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Sheffer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789877
org study id: I 72218
secondary id: NCI-2018-03302
secondary id: I 72218
nct id: NCT03789877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Delay discounting score
time frame: Baseline up to 6 months
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.
measure: Number of steps per day
time frame: Baseline up to 6 months
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.
measure: Number of minutes of moderate physical activity per day
time frame: Baseline up to 6 months
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.
arm group label: Group I (home-based walking program, rTMS)
arm group type: Experimental
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 group label: Group II (home-based exercise program, sham rTMS)
arm group type: Active Comparator
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: Physical Activity
description: Participate in home-based walking program
arm group label: Group I (home-based walking program, rTMS)
arm group label: Group II (home-based exercise program, sham rTMS)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (home-based walking program, rTMS)
arm group label: Group II (home-based exercise program, sham rTMS)
intervention type: Procedure
intervention name: Repetitive Transcranial Magnetic Stimulation
description: Undergo rTMS
arm group label: Group I (home-based walking program, rTMS)
other name: rTMS
intervention type: Procedure
intervention name: Sham Intervention
description: Undergo sham rTMS
arm group label: Group II (home-based exercise program, sham rTMS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Christine Sheffer
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms