<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/NCT01719562</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00020968</org_study_id>
    <secondary_id>NCI-2012-01613</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <secondary_id>CCCWFU 99112</secondary_id>
    <secondary_id>R01CA167821</secondary_id>
    <secondary_id>R21CA226960</secondary_id>
    <nct_id>NCT01719562</nct_id>
  </id_info>
  <brief_title>MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum</brief_title>
  <official_title>Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 &quot;Early Imaging Detection of Cardiovascular Injury After Cancer&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage&#xD;
      in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help&#xD;
      doctors predict whether patients will have heart damage caused by chemotherapy in patients&#xD;
      with cancer receiving chemotherapy.&#xD;
&#xD;
      Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility&#xD;
      of performing the physical activity intervention and the primary outcome measures before,&#xD;
      during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma.&#xD;
      This study will test the potential for a novel (lifestyle) intervention designed to improve&#xD;
      exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This&#xD;
      data will inform the development of the R33 phase of the clinical trial to determine if the&#xD;
      physical activity intervention can reduce exercise intolerance in this high-risk population.&#xD;
      In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac&#xD;
      MRI data from individuals in the parent study that did not undergo either of the two&#xD;
      interventional arms of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To design an automated MRI hardware/software platform for measuring and reporting left&#xD;
      ventricular (LV) function (volumes, strain, and ejection fraction [EF]), T1 myocardial&#xD;
      signal, and aortic pulse wave velocity (PWV).&#xD;
&#xD;
      II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes&#xD;
      in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic&#xD;
      PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline,&#xD;
      3 months, and 24 months.&#xD;
&#xD;
      Exercise Capacity Addendum Objectives:&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        -  To provide critical participant enrollment data necessary to accomplish the R01&#xD;
           submission, including:&#xD;
&#xD;
        -  Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and&#xD;
           stage I-IV breast cancer patients including the reasons for failed randomization,&#xD;
&#xD;
        -  Identification of barriers for participating in, or adhering to the Patient ES-AI and&#xD;
           the Healthy Living Control Group.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      • In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or&#xD;
      other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak&#xD;
      exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum&#xD;
      rate of oxygen), and pre-exercise measures of left ventricular and cognitive function,&#xD;
      health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment&#xD;
      of the left ventricular function and health-related rate quality of life will be attempted in&#xD;
      a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the&#xD;
      parent study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">March 8, 2022</completion_date>
  <primary_completion_date type="Actual">March 8, 2022</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>
    <intervention_model_description>For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Completing the Trial (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>The number of participants who completed the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>Number of participants who completed the 6-minute walk test at 6-months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak Exercise Cardiac Output (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Function (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Distance (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)</measure>
    <time_frame>6 months after treatment initiation</time_frame>
    <description>The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Cardiac Toxicity</condition>
  <condition>Malignant Neoplasm</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>ADDENDUM: Physical Activity Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ADDENDUM: Healthy Living Instruction Group (Control Arm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRI (Diagnostic)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <description>Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.</description>
    <arm_group_label>ADDENDUM: Healthy Living Instruction Group (Control Arm)</arm_group_label>
    <arm_group_label>ADDENDUM: Physical Activity Intervention</arm_group_label>
    <arm_group_label>MRI (Diagnostic)</arm_group_label>
    <other_name>MRI</other_name>
    <other_name>NMR imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>nuclear magnetic resonance imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>Tailored aerobic exercise program onsite and at home.</description>
    <arm_group_label>ADDENDUM: Physical Activity Intervention</arm_group_label>
    <arm_group_label>MRI (Diagnostic)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Living</intervention_name>
    <description>Healthy living presentations at a centralized meeting place and over the phone.</description>
    <arm_group_label>ADDENDUM: Healthy Living Instruction Group (Control Arm)</arm_group_label>
    <arm_group_label>MRI (Diagnostic)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiopulmonary Exercise Testing (CPET)</intervention_name>
    <description>Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.</description>
    <arm_group_label>ADDENDUM: Healthy Living Instruction Group (Control Arm)</arm_group_label>
    <arm_group_label>ADDENDUM: Physical Activity Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>A self-administered 13-item scale to assess fatigue in participants</description>
    <arm_group_label>ADDENDUM: Healthy Living Instruction Group (Control Arm)</arm_group_label>
    <arm_group_label>ADDENDUM: Physical Activity Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PARENT STUDY:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Receiving &gt;= 350 mg/m^2 of Anth-bC therapy, or a combination of Anth-bC (&gt;= 250&#xD;
             mg/m^2) and subsequent paclitaxel or Herceptin&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices,&#xD;
             or other implanted electronic devices&#xD;
&#xD;
          -  Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal&#xD;
&#xD;
          -  Allergy to gadolinium or other severe drug allergies&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Significant ventricular arrhythmias (&gt; 20 premature ventricular contractions&#xD;
             [PVCs]/minute due to gating difficulty)&#xD;
&#xD;
          -  Acute myocardial infarction within 28 days&#xD;
&#xD;
          -  Atrial fibrillation with uncontrolled ventricular response&#xD;
&#xD;
          -  Moderate or severe aortic stenosis&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Congestive heart failure (New York Heart Association [NYHA] class III or IV)&#xD;
&#xD;
          -  Significant valvular disease, or significant pulmonary disease requiring supplemental&#xD;
             oxygen therapy&#xD;
&#xD;
          -  Participants unwilling to complete the protocol (24 month duration)&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Patients unable or unwilling to provide informed consent&#xD;
&#xD;
        EXERCISE CAPACITY ADDENDUM:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18-85 with non- or Hodgkin lymphoma or I-IV stage breast cancer&#xD;
             patients that expect to receive an anthracycline based chemotherapeutic regimen or&#xD;
             other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens&#xD;
             [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors&#xD;
             [ICI's]) or radiation (within 8 weeks of completion).&#xD;
&#xD;
          -  Potential enrollees will need the capacity to walk at least two (2) city blocks on a&#xD;
             flat surface.&#xD;
&#xD;
          -  English speaking participants only will be enrolled.&#xD;
&#xD;
          -  Stage IV breast cancer participants must have a 2 year survival prognosis and approval&#xD;
             from their physician.&#xD;
&#xD;
        Exclusion Criteria: The following are relative contraindications and can be considered by&#xD;
        the medical director of the study:&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure &gt;190 mm Hg or diastolic blood&#xD;
             pressure &gt;100 mm Hg)&#xD;
&#xD;
          -  A recent history of alcohol or drug abuse.&#xD;
&#xD;
          -  Inflammatory conditions such as lupus or inflammatory bowel disease, or another&#xD;
             medical condition that might compromise safety or successful completion.&#xD;
&#xD;
          -  Other exclusions include those with contraindications to MRI such as ferromagnetic&#xD;
             cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators,&#xD;
             functioning neurostimulator devices or other implanted electronic devices.&#xD;
&#xD;
          -  Unstable angina.&#xD;
&#xD;
          -  Inability to exercise on a treadmill or stationary cycle.&#xD;
&#xD;
          -  Significant ventricular arrhythmias (&gt;20 PVCs/min due to gating difficulty).&#xD;
&#xD;
          -  Atrial fibrillation with uncontrolled ventricular response.&#xD;
&#xD;
          -  Acute myocardial infarction within 28 days.&#xD;
&#xD;
          -  Moving within 12 months of enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Hundley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Health Sciences</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>March 1, 2023</results_first_submitted>
  <results_first_submitted_qc>April 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2023</results_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</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>Neoplasms</mesh_term>
    <mesh_term>Cardiotoxicity</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT01719562/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT01719562/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ADDENDUM: Physical Activity Intervention</title>
          <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
        <group group_id="P2">
          <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
          <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>New cancer diagnosis</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ADDENDUM: Physical Activity Intervention</title>
          <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
        <group group_id="B2">
          <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
          <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.5" spread="16.8"/>
                    <measurement group_id="B2" value="56.8" spread="12.7"/>
                    <measurement group_id="B3" value="53.65" spread="16.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis: Hodgkin Lympoma, Non-Hodgkin Lymphoma, Breast Cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hodgkin Lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hodgkin Lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Breast Cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Completing the Trial (Exercise Capacity Addendum)</title>
        <description>The number of participants who completed the intervention.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Completing the Trial (Exercise Capacity Addendum)</title>
          <description>The number of participants who completed the intervention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)</title>
        <description>Number of participants who completed the 6-minute walk test at 6-months.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)</title>
          <description>Number of participants who completed the 6-minute walk test at 6-months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Exercise Cardiac Output (Exercise Capacity Addendum)</title>
        <description>Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.</description>
        <time_frame>6 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Exercise Cardiac Output (Exercise Capacity Addendum)</title>
          <description>Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.</description>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16900" spread="3350"/>
                    <measurement group_id="O2" value="15700" spread="4100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)</title>
        <description>Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)</title>
          <description>Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.</description>
          <population>Hospital restrictions due to COVID-19 prevented the data collection of A-V O2 on all participants who completed the study.</population>
          <units>mL/100 mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00182" spread="0.000322"/>
                    <measurement group_id="O2" value="0.00150" spread="0.000362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)</title>
        <description>Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)</title>
          <description>Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.</description>
          <population>Hospital restrictions due to COVID-19 prevented the data collection of VO2 on all participants who completed the study.</population>
          <units>mL/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6" spread="5.83"/>
                    <measurement group_id="O2" value="23.6" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Function (Exercise Capacity Addendum)</title>
        <description>Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Function (Exercise Capacity Addendum)</title>
          <description>Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.</description>
          <population>Hospital restrictions due to COVID-19 prevented the data collection of LVEF on all participants who completed the study.</population>
          <units>LVEF Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3" spread="8.06"/>
                    <measurement group_id="O2" value="65.1" spread="5.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)</title>
        <description>The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)</title>
          <description>The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.</description>
          <population>Hospital restrictions due to COVID-19 prevented the data collection of the COWA test on all participants who completed the study.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.5" spread="9.53"/>
                    <measurement group_id="O2" value="39.3" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health-Related Quality of Life (Exercise Capacity Addendum)</title>
        <description>The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Some participants refused or failed to complete the FACT-Lym survey at 6-months.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Health-Related Quality of Life (Exercise Capacity Addendum)</title>
          <description>The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.</description>
          <population>Some participants refused or failed to complete the FACT-Lym survey at 6-months.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3" spread="10.3"/>
                    <measurement group_id="O2" value="76.6" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6-minute Walk Distance (Exercise Capacity Addendum)</title>
        <description>The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>6-minute Walk Distance (Exercise Capacity Addendum)</title>
          <description>The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543" spread="90.6"/>
                    <measurement group_id="O2" value="457" spread="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)</title>
        <description>The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.</description>
        <time_frame>6 months after treatment initiation</time_frame>
        <population>Some participants refused or failed to complete the FACT-Fatigue survey at 6-months.</population>
        <group_list>
          <group group_id="O1">
            <title>ADDENDUM: Physical Activity Intervention</title>
            <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
          <group group_id="O2">
            <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
            <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)</title>
          <description>The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.</description>
          <population>Some participants refused or failed to complete the FACT-Fatigue survey at 6-months.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="6.20"/>
                    <measurement group_id="O2" value="32.4" spread="8.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ADDENDUM: Physical Activity Intervention</title>
          <description>Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Physical Activity: Tailored aerobic exercise program onsite and at home.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
        <group group_id="E2">
          <title>ADDENDUM: Healthy Living Instruction Group (Control Arm)</title>
          <description>Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .&#xD;
Magnetic resonance imaging: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.&#xD;
Healthy Living: Healthy living presentations at a centralized meeting place and over the phone.&#xD;
Cardiopulmonary Exercise Testing (CPET): Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.&#xD;
Questionnaire Administration: A self-administered 13-item scale to assess fatigue in participants</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea due to home-based exercise session</sub_title>
                <description>Participant experienced nausea during online kickboxing class. Recovered within 2 hours after exercise. Adjusted exercise recommendation to stay below high HR ranges. Participant completed the study.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Project Manager</name_or_title>
      <organization>Wake Forest University</organization>
      <phone>+1(336) 758-3728</phone>
      <email>jvolpini@wakehealth.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01719562
org study id: IRB00020968
secondary id: NCI-2012-01613
secondary id: P30CA012197
secondary id: CCCWFU 99112
secondary id: R01CA167821
secondary id: R21CA226960
nct id: NCT01719562
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage
      in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help
      doctors predict whether patients will have heart damage caused by chemotherapy in patients
      with cancer receiving chemotherapy.

      Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility
      of performing the physical activity intervention and the primary outcome measures before,
      during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma.
      This study will test the potential for a novel (lifestyle) intervention designed to improve
      exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This
      data will inform the development of the R33 phase of the clinical trial to determine if the
      physical activity intervention can reduce exercise intolerance in this high-risk population.
      In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac
      MRI data from individuals in the parent study that did not undergo either of the two
      interventional arms of this study.
PRIMARY OBJECTIVES:

      I. To design an automated MRI hardware/software platform for measuring and reporting left
      ventricular (LV) function (volumes, strain, and ejection fraction [EF]), T1 myocardial
      signal, and aortic pulse wave velocity (PWV).

      II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes
      in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic
      PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.

      OUTLINE:

      Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline,
      3 months, and 24 months.

      Exercise Capacity Addendum Objectives:

      Primary Objective:

        -  To provide critical participant enrollment data necessary to accomplish the R01
           submission, including:

        -  Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and
           stage I-IV breast cancer patients including the reasons for failed randomization,

        -  Identification of barriers for participating in, or adhering to the Patient ES-AI and
           the Healthy Living Control Group.

      Secondary Objective:

      • In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or
      other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak
      exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum
      rate of oxygen), and pre-exercise measures of left ventricular and cognitive function,
      health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment
      of the left ventricular function and health-related rate quality of life will be attempted in
      a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the
      parent study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants Completing the Trial (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: The number of participants who completed the intervention.
measure: Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: Number of participants who completed the 6-minute walk test at 6-months.
measure: Peak Exercise Cardiac Output (Exercise Capacity Addendum)
time frame: 6 months after treatment
description: Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.
measure: Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.
measure: Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.
measure: Left Ventricular Function (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.
measure: Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.
measure: Health-Related Quality of Life (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.
measure: 6-minute Walk Distance (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.
measure: Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)
time frame: 6 months after treatment initiation
description: The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.
arm group label: ADDENDUM: Physical Activity Intervention
arm group type: Experimental
description: Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
arm group label: ADDENDUM: Healthy Living Instruction Group (Control Arm)
arm group type: Experimental
description: Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
arm group label: MRI (Diagnostic)
arm group type: Experimental
description: Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
intervention type: Procedure
intervention name: Magnetic resonance imaging
description: Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
arm group label: ADDENDUM: Healthy Living Instruction Group (Control Arm)
arm group label: ADDENDUM: Physical Activity Intervention
arm group label: MRI (Diagnostic)
other name: MRI
other name: NMR imaging
other name: NMRI
other name: nuclear magnetic resonance imaging
intervention type: Other
intervention name: Physical Activity
description: Tailored aerobic exercise program onsite and at home.
arm group label: ADDENDUM: Physical Activity Intervention
arm group label: MRI (Diagnostic)
intervention type: Other
intervention name: Healthy Living
description: Healthy living presentations at a centralized meeting place and over the phone.
arm group label: ADDENDUM: Healthy Living Instruction Group (Control Arm)
arm group label: MRI (Diagnostic)
intervention type: Device
intervention name: Cardiopulmonary Exercise Testing (CPET)
description: Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
arm group label: ADDENDUM: Healthy Living Instruction Group (Control Arm)
arm group label: ADDENDUM: Physical Activity Intervention
intervention type: Other
intervention name: Questionnaire Administration
description: A self-administered 13-item scale to assess fatigue in participants
arm group label: ADDENDUM: Healthy Living Instruction Group (Control Arm)
arm group label: ADDENDUM: Physical Activity Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: William Hundley
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplasms
mesh term: Cardiotoxicity
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 