<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/NCT03039140</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-14060</org_study_id>
    <secondary_id>NCI-2015-00810</secondary_id>
    <nct_id>NCT03039140</nct_id>
  </id_info>
  <brief_title>Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors</brief_title>
  <official_title>A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory&#xD;
      fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause&#xD;
      of death of women in both the general population and the breast cancer survivor population.&#xD;
      There are many risk factors common to both heart disease and breast cancer development,&#xD;
      including physical inactivity. A cardiac rehabilitation program may help improve&#xD;
      cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of&#xD;
      life among breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in&#xD;
      women with breast cancer after completion of acute therapy.&#xD;
&#xD;
      II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak&#xD;
      oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.&#xD;
&#xD;
      III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure,&#xD;
      cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up.&#xD;
      Blood pressure and body mass index will also be checked at 8 weeks.&#xD;
&#xD;
      IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week&#xD;
      follow up, adjusting for baseline QoL values.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on&#xD;
      a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions).&#xD;
      Components of the exercise prescription includes intensity, mode, duration, and frequency.&#xD;
      Intensity of exercise is guided by the results of a graded exercise stress test, rating of&#xD;
      perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of&#xD;
      breath. If exercise is well-tolerated during CR sessions, patients are encouraged to&#xD;
      supplement their exercise program at home, increasing their exercise frequency to up to 5&#xD;
      times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR&#xD;
      program which covers topics such as stress management, smoking cessation, nutrition, and&#xD;
      weight loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2015</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 23, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of conducting a 14-week CR program</measure>
    <time_frame>14 weeks</time_frame>
    <description>During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of CR in improving cardiorespiratory fitness</measure>
    <time_frame>At 14 weeks</time_frame>
    <description>Analysis of follow-up VO2 max, in units of mL/kg/min, will be done using an analysis of covariance (ANCOVA) approach. If VO2 max values are missing at 14 weeks, will use the Duke Activity Status Index questionnaire responses to approximate VO2 max values.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>Stage 0 Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage IIA Breast Cancer</condition>
  <condition>Stage IIB Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Supportive care (CR program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Attend weekly educational sessions</description>
    <arm_group_label>Supportive care (CR program)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Participate in CR program</description>
    <arm_group_label>Supportive care (CR program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (CR program)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (CR program)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with breast cancer stages 0-III within 6 months after completion of all&#xD;
             planned surgery, radiation and or chemotherapy treatments&#xD;
&#xD;
          -  Concurrent endocrine therapy permissible&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent&#xD;
&#xD;
          -  Willingness to participate in CR program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing CVD&#xD;
&#xD;
          -  Existing diabetes&#xD;
&#xD;
          -  Contraindications to exercise&#xD;
&#xD;
          -  Metastatic breast cancer&#xD;
&#xD;
          -  Other concurrent malignancies except skin cancer&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, or psychiatric illness/social situation that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Any contraindication to cardiac stress testing&#xD;
&#xD;
          -  Travel distance greater than 50 miles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maryam Lustberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>March 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</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>
    <mesh_term>Breast Carcinoma In Situ</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/NCT03039140
org study id: OSU-14060
secondary id: NCI-2015-00810
nct id: NCT03039140
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory
      fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause
      of death of women in both the general population and the breast cancer survivor population.
      There are many risk factors common to both heart disease and breast cancer development,
      including physical inactivity. A cardiac rehabilitation program may help improve
      cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of
      life among breast cancer survivors.
PRIMARY OBJECTIVES:

      I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in
      women with breast cancer after completion of acute therapy.

      II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak
      oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.

      III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure,
      cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up.
      Blood pressure and body mass index will also be checked at 8 weeks.

      IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week
      follow up, adjusting for baseline QoL values.

      OUTLINE:

      Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on
      a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions).
      Components of the exercise prescription includes intensity, mode, duration, and frequency.
      Intensity of exercise is guided by the results of a graded exercise stress test, rating of
      perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of
      breath. If exercise is well-tolerated during CR sessions, patients are encouraged to
      supplement their exercise program at home, increasing their exercise frequency to up to 5
      times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR
      program which covers topics such as stress management, smoking cessation, nutrition, and
      weight loss.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of conducting a 14-week CR program
time frame: 14 weeks
description: During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.
measure: Efficacy of CR in improving cardiorespiratory fitness
time frame: At 14 weeks
description: Analysis of follow-up VO2 max, in units of mL/kg/min, will be done using an analysis of covariance (ANCOVA) approach. If VO2 max values are missing at 14 weeks, will use the Duke Activity Status Index questionnaire responses to approximate VO2 max values.
arm group label: Supportive care (CR program)
arm group type: Experimental
description: Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
intervention type: Other
intervention name: Educational Intervention
description: Attend weekly educational sessions
arm group label: Supportive care (CR program)
other name: Education for Intervention
other name: Intervention, Educational
intervention type: Behavioral
intervention name: Exercise Intervention
description: Participate in CR program
arm group label: Supportive care (CR program)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive care (CR program)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive care (CR program)
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Maryam Lustberg, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Carcinoma In Situ