<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/NCT02969291</url>
  </required_header>
  <id_info>
    <org_study_id>776553-5</org_study_id>
    <nct_id>NCT02969291</nct_id>
  </id_info>
  <brief_title>A Home-Based Study to Enhance Activity in Breast Cancer Survivors</brief_title>
  <official_title>A Home-Based Study to Enhance Activity in Breast Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baystate Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Massachusetts, Amherst</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baystate Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a well-documented association between physical activity &amp; risk for breast cancer&#xD;
      development and recurrence. It is known that exercise interventions have been effective at&#xD;
      increasing physical activity levels in breast cancer survivors. Knowing that breast cancer&#xD;
      survivors are less active than non-cancer patients, a less active lifestyle places them at&#xD;
      risk of obesity and poor overall health, which in turn also increases risk of cancer and&#xD;
      cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known&#xD;
      that hormones and other inflammatory markers play a role.&#xD;
&#xD;
      This study has three goals:&#xD;
&#xD;
        1. To investigate the feasibility of a home intervention designed to reduce sedentary&#xD;
           behavior.&#xD;
&#xD;
        2. Describe the effects of the intervention on levels of sedentary behavior, physical&#xD;
           activity, and symptoms.&#xD;
&#xD;
        3. Assess cost of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a well-documented association between physical activity and risk for breast cancer&#xD;
      development and recurrence. Exercise training interventions have been effective at increasing&#xD;
      physical activity levels in breast cancer survivors, however they require 1) a large degree&#xD;
      of patient initiative to achieve positive health outcomes associated with sustained&#xD;
      behavioral change and 2) facilities and oversight that may be prohibitive in a clinical&#xD;
      setting. Although most activity-based research to date has focused on increasing levels of&#xD;
      moderate to vigorous physical activity (MVPA) for breast cancer survivors, large&#xD;
      epidemiological studies suggest that breast cancer survivors are also more sedentary when&#xD;
      compared to non-cancer controls. A recent meta-analysis of controlled intervention trials&#xD;
      designed to promote physical activity among sedentary cancer survivors found that none of the&#xD;
      trials within the scope of the review succeeded in achieving 75% or better adherence to&#xD;
      prescribed exercise guidelines, leading the authors to question whether shifting the target&#xD;
      of intervention from MVPA to reductions in sedentary time might be a more realistic goal.&#xD;
      Recent research suggests that interventions designed to reduce sedentary time in breast&#xD;
      cancer survivors have the potential to yield clinically meaningful health benefits,&#xD;
      especially for individuals at higher risk for sedentary behaviors, however the optimal method&#xD;
      of intervention is not clear.&#xD;
&#xD;
      Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to&#xD;
      reduce sedentary behavior in breast cancer survivors. The behavioral intervention will&#xD;
      involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity&#xD;
      patterns, combined with tailored activity prompts described over the following 6 weeks.&#xD;
&#xD;
      Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of&#xD;
      the intervention on levels of sedentary behavior, physical activity and symptoms of cancer&#xD;
      survivorship (e.g. cancer related fatigue).&#xD;
&#xD;
      Aim 2b: Evaluate the relationship between change in sedentary behavior and change in&#xD;
      cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1,&#xD;
      Leptin), following the reduced sedentary time intervention.&#xD;
&#xD;
      Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of&#xD;
      the intervention and its individual components, dose delivered and dose received by&#xD;
      intervention participants Aim 3b: Quantitatively describe intervention participants'&#xD;
      perspectives on the impact of the individual intervention components, including which&#xD;
      components appeared most useful for reducing sedentary time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sedentary Time</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Activity level as recorded by Actigraph monitor in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in fasting glucose ( mmol/L)in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in insulin (pmol/L) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in total cholesterol (mmol) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High density lipoprotien cholesterol</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in high density lipoprotein cholesterol (mmol) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in triglycerides (mmol) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Body Mass Index (kg/m2) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in waist circumference in cm in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in systolic blood pressure measured in mmHg in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in diastolic blood pressure measured in mmHg in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary behavior self -efficacy</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EORTC-QLQ-C30 scores in all 25 participants</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Intervention</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Reduced Sedentary Time Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Reduced Sedentary Time Intervention (RSTI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reduced Sedentary Time Intervention (RSTI)</intervention_name>
    <description>Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.</description>
    <arm_group_label>Reduced Sedentary Time Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage I-III breast cancer survivors 20-80 who have completed primary treatment&#xD;
             (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years&#xD;
             ago. Patients may be on adjuvant hormonal therapy&#xD;
&#xD;
          -  BMI &gt; 25 (overweight or class I/II obese)&#xD;
&#xD;
          -  Not meeting current guidelines for regular exercise as defined by less than 150&#xD;
             minutes a week of moderate to vigorous physical activity&#xD;
&#xD;
          -  No gain or loss of &gt;10% body weight over the prior 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known diabetes&#xD;
&#xD;
          -  Known coronary artery disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any injury that would limit mobility or require use of assisted mobility devices&#xD;
&#xD;
          -  Weight gain or loss of &gt;10% body weight over the prior 6 months&#xD;
&#xD;
          -  Greater than 150 minutes a week of moderate to vigorous physical activity&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Non-english speaking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace Makari-Judson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baystate Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2019</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02969291
org study id: 776553-5
nct id: NCT02969291
lead sponsor: 
collaborator: 
has dmc: No
There is a well-documented association between physical activity & risk for breast cancer
      development and recurrence. It is known that exercise interventions have been effective at
      increasing physical activity levels in breast cancer survivors. Knowing that breast cancer
      survivors are less active than non-cancer patients, a less active lifestyle places them at
      risk of obesity and poor overall health, which in turn also increases risk of cancer and
      cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known
      that hormones and other inflammatory markers play a role.

      This study has three goals:

        1. To investigate the feasibility of a home intervention designed to reduce sedentary
           behavior.

        2. Describe the effects of the intervention on levels of sedentary behavior, physical
           activity, and symptoms.

        3. Assess cost of the intervention.
There is a well-documented association between physical activity and risk for breast cancer
      development and recurrence. Exercise training interventions have been effective at increasing
      physical activity levels in breast cancer survivors, however they require 1) a large degree
      of patient initiative to achieve positive health outcomes associated with sustained
      behavioral change and 2) facilities and oversight that may be prohibitive in a clinical
      setting. Although most activity-based research to date has focused on increasing levels of
      moderate to vigorous physical activity (MVPA) for breast cancer survivors, large
      epidemiological studies suggest that breast cancer survivors are also more sedentary when
      compared to non-cancer controls. A recent meta-analysis of controlled intervention trials
      designed to promote physical activity among sedentary cancer survivors found that none of the
      trials within the scope of the review succeeded in achieving 75% or better adherence to
      prescribed exercise guidelines, leading the authors to question whether shifting the target
      of intervention from MVPA to reductions in sedentary time might be a more realistic goal.
      Recent research suggests that interventions designed to reduce sedentary time in breast
      cancer survivors have the potential to yield clinically meaningful health benefits,
      especially for individuals at higher risk for sedentary behaviors, however the optimal method
      of intervention is not clear.

      Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to
      reduce sedentary behavior in breast cancer survivors. The behavioral intervention will
      involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity
      patterns, combined with tailored activity prompts described over the following 6 weeks.

      Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of
      the intervention on levels of sedentary behavior, physical activity and symptoms of cancer
      survivorship (e.g. cancer related fatigue).

      Aim 2b: Evaluate the relationship between change in sedentary behavior and change in
      cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1,
      Leptin), following the reduced sedentary time intervention.

      Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of
      the intervention and its individual components, dose delivered and dose received by
      intervention participants Aim 3b: Quantitatively describe intervention participants'
      perspectives on the impact of the individual intervention components, including which
      components appeared most useful for reducing sedentary time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sedentary Time
time frame: 8 weeks
description: Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
measure: Activity Level
time frame: 8 weeks
description: Change in Activity level as recorded by Actigraph monitor in all 25 participants
measure: Glucose
time frame: 8 weeks
description: Change in fasting glucose ( mmol/L)in all 25 participants
measure: Insulin
time frame: 8 weeks
description: Change in insulin (pmol/L) in all 25 participants
measure: Total cholesterol
time frame: 8 weeks
description: Change in total cholesterol (mmol) in all 25 participants
measure: High density lipoprotien cholesterol
time frame: 8 weeks
description: Change in high density lipoprotein cholesterol (mmol) in all 25 participants
measure: Triglyceride
time frame: 8 weeks
description: Change in triglycerides (mmol) in all 25 participants
measure: Body Mass Index
time frame: 8 weeks
description: Change in Body Mass Index (kg/m2) in all 25 participants
measure: Waist Circumference
time frame: 8 weeks
description: Change in waist circumference in cm in all 25 participants
measure: Systolic Blood pressure
time frame: 8 weeks
description: Change in systolic blood pressure measured in mmHg in all 25 participants
measure: Diastolic Blood pressure
time frame: 8 weeks
description: Change in diastolic blood pressure measured in mmHg in all 25 participants
measure: Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants
time frame: 8 weeks
measure: Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
time frame: 8 weeks
measure: Sedentary behavior self -efficacy
time frame: 8 weeks
description: Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants
measure: Change in EORTC-QLQ-C30 scores in all 25 participants
time frame: 8 weeks
measure: Assessment of Intervention
time frame: 8 weeks
description: Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants
arm group label: Reduced Sedentary Time Intervention
arm group type: Other
description: Reduced Sedentary Time Intervention (RSTI)
intervention type: Behavioral
intervention name: Reduced Sedentary Time Intervention (RSTI)
description: Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.
arm group label: Reduced Sedentary Time Intervention
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Grace Makari-Judson, MD
role: Principal Investigator
affiliation: Baystate Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided