<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/NCT03760536</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 1630</org_study_id>
    <nct_id>NCT03760536</nct_id>
  </id_info>
  <brief_title>Get REAL and HEEL Research Program</brief_title>
  <official_title>Get REAL and HEEL Research Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The UNC Get REAL &amp; HEEL (GR&amp;H) program has provided after treatment support for women with a&#xD;
      breast cancer diagnosis since 2006. The 16-week program includes an individualized training&#xD;
      program and the opportunity to continue working out in the GR&amp;H facilities at the conclusion&#xD;
      of the 16-week program. The purpose of this protocol is to implement a research agenda at&#xD;
      GR&amp;H that will examine the efficacy of the program. The primary aim of this study is a&#xD;
      pre-post test of the impact of the GR&amp;H program (standardized combination of aerobic and&#xD;
      resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality&#xD;
      of life as well as cardiorespiratory function (vascular health), physical function (muscular&#xD;
      strength, body composition), cognition, balance, and patient-reported outcomes (fatigue,&#xD;
      depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact&#xD;
      of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte&#xD;
      count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3)&#xD;
      circulating pro- and anti-inflammatory cytokines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      Evaluate the impact of the Get REAL and HEEL research program (standardized combination of&#xD;
      aerobic and resistance training) on change in V02peak from pre to post 16-week intervention.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
      Evaluate the impact of the GR&amp;H program (standardized combination of aerobic and resistance&#xD;
      training) on change in cardiorespiratory function, immunology, physical function parameters,&#xD;
      cognition, balance, and patient-reported outcomes from pre to post 16-week intervention.&#xD;
&#xD;
      Evaluate changes in all measures annually over the 5 year follow-up period.&#xD;
&#xD;
      Report on enrollment, recruitment, and attrition.&#xD;
&#xD;
      Exploratory Objectives&#xD;
&#xD;
      The investigator's exploratory aims are focused on evaluating the impact of exercise on&#xD;
      biomarkers: (1) aging - p16INK4a, (2) total leukocyte, lymphocyte (T cells and natural killer&#xD;
      cells), monocyte and neutrophil counts and T cell proliferation assays, natural killer&#xD;
      cytotoxicity assays, and cytokine production from stimulated neutrophils and monocytes, and&#xD;
      (3) circulating pro- and anti-inflammatory cytokines.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants will complete pre-intervention assessments, questionnaires and blood draw at&#xD;
      week 1 and 2 pre-intervention, followed by a 16-week aerobic and resistance training exercise&#xD;
      program (intervention). Participants will complete assessments, questionnaires and blood&#xD;
      draws at week 1 and 2 following the intervention and then again at 6 months and 12 months&#xD;
      following intervention. Questionnaires only will be administered at year 2, 3,4 and 5&#xD;
      following intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Cardiopulmonary exercise test with NIRS and PWA (vascular function)</measure>
    <time_frame>Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention</time_frame>
    <description>The Cardiopulmonary Exercise Test (CPET) with NIRS and PWA will be used to measure peak oxygen content (VO2peak), tissue oxygen saturation and pulse wave analysis during this symptom-limited exercise test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics-Height</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention</time_frame>
    <description>Measure Height</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics-Weight</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention</time_frame>
    <description>Weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics-BMI</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention</time_frame>
    <description>Measure BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics-Blood Pressure</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention</time_frame>
    <description>Measure blood pressure -- both systolic and diastolic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics-Resting Heart Rate</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention</time_frame>
    <description>Measure Resting Heart Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention</time_frame>
    <description>DEXA -- Body Composition will be perfomed using a Hologic (Discovery W) Dual X-ray Absorptiometry (DEXA) located in the EORL. Total body weight-mass (BW) and compositional aspects of lean body mass (LBM), fat tissue mass (FM), and percentage body fat (% BF) will be examined using standard DEXA screening procedures. The BW will be measured using a high grade analytical balance-scale (accuracy ± 10 grams).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of muscle composition -- proportion of body fat to lean muscle mass</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Ultrasound -- LogicView™ software (General Electric Company, Milwaukee, WI, USA) will be used to generate real-time panoramic cross-sectional images of the VL. Three panoramic scans at a gain of 50dB and a depth of 5.0 cm. All image analyses will be completed using Image-J software (version 1.46r, National Institutes of Health, USA) with each image area individually scaled from pixels to centimeters via the straight-line function. The polygon function will be used to determine the CSA of the VL by selecting a region including mostly muscle and minimal surrounding fascia. Greater EI values represent greater fibrous (non-muscular) composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Function</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>XCEL Sphygmacor+USCOM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting ECG</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Resting electrocardiogram -- Individual wave/complex/intervals components and overall ECG tracings will be assessed using a 12-lead ECG. The study Cardiologist will review each report individually at baseline prior to the Cardiopulmonary Exercise Test for evidence of overt cardiac dysfunction and will deem the potential study participant appropriate/not appropriate for exercise testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Tests</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>6-minute walk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Tests</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Timed Up and Go</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer DKEFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer Digit Span</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer Sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer HVLT-R</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer TMT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Testing</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer NeuroCom balance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength and Power</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Isokinetic, isometric handgrip tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Draw</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>30 mL Blood draw for non-subset group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with GR&amp;H Questionnaire</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Administer Satisfaction with GR&amp;H Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only)</measure>
    <time_frame>Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention</time_frame>
    <description>Cannulated, 3 blood draws over course of 45 minute visit. 50 mL total collected pre-intervention and post intervention; 30 mL total collected at 6 months and 12 months post-intervention</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>16-week Exercise Program</arm_group_label>
    <description>Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>16-week Exercise Rehabilitation Program for Breast Cancer Survivors</intervention_name>
    <description>Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.</description>
    <arm_group_label>16-week Exercise Program</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood draw for p16 analysis and immune/inflammatory parameters&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Potential study participants with confirmed early-stage breast cancer will be screened&#xD;
        through a review of daily clinic schedules for patients seen at the North Carolina Cancer&#xD;
        Hospital. Patients must have recently completed their initial treatment (be within one year&#xD;
        of completion).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be eligible for this protocol if they have&#xD;
&#xD;
          -  histologically confirmed early stage (non-metastatic) breast cancer&#xD;
&#xD;
          -  and have recently (within 1 year) completed their initial treatment (they may continue&#xD;
             to be on endocrine treatment).&#xD;
&#xD;
        No exclusions will be made based on ethnicity or race, although patients must be able to&#xD;
        read and speak English.&#xD;
&#xD;
        Participants must provide IRB-approved signed written informed consent. The consent&#xD;
        includes access to their medical records, including demographic and billing information,&#xD;
        diagnoses, treatments, and laboratory results. Participants may also be asked to provide&#xD;
        permission to contact their non-UNC doctors for additional medical record information, and&#xD;
        may also require a medical release from various treating physicians.&#xD;
&#xD;
        Interested persons must agree to adhere to the 16-week GR&amp;H protocol and complete all blood&#xD;
        draws, assessments and questionnaires to the best of their ability. The informed consent&#xD;
        will also include annual follow-up assessments and questionnaires for up to 5 years after&#xD;
        they have completed the 16-week program.&#xD;
&#xD;
        Patients who are approached about participating in LCCC1630 and decline to do so are able&#xD;
        to join GR&amp;H as a supportive care program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Interested persons will be excluded from study participation if&#xD;
&#xD;
          -  they do not have evidence of a cancer diagnosis or completion of surgery, radiation&#xD;
             and/or chemotherapy treatment,&#xD;
&#xD;
          -  or if they have previously completed the GR&amp;H exercise program. Entirely at the&#xD;
             discretion of GR&amp;H investigators, physical function and other assessments conducted at&#xD;
             baseline may also determine that a patient is not medically suitable for the GR&amp;H&#xD;
             protocol. Consented patients who are determined to be medically not suited for the&#xD;
             GR&amp;H protocol (unevaluable) will remain in the study for analyses comparing those who&#xD;
             are evaluable with those who are not.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio L Battaglini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten Nyrop</last_name>
    <role>Study Director</role>
    <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Carolina Cancer Hospital</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03760536
org study id: LCCC 1630
nct id: NCT03760536
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The UNC Get REAL & HEEL (GR&H) program has provided after treatment support for women with a
      breast cancer diagnosis since 2006. The 16-week program includes an individualized training
      program and the opportunity to continue working out in the GR&H facilities at the conclusion
      of the 16-week program. The purpose of this protocol is to implement a research agenda at
      GR&H that will examine the efficacy of the program. The primary aim of this study is a
      pre-post test of the impact of the GR&H program (standardized combination of aerobic and
      resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality
      of life as well as cardiorespiratory function (vascular health), physical function (muscular
      strength, body composition), cognition, balance, and patient-reported outcomes (fatigue,
      depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact
      of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte
      count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3)
      circulating pro- and anti-inflammatory cytokines.
Objectives:

      Primary:

      Evaluate the impact of the Get REAL and HEEL research program (standardized combination of
      aerobic and resistance training) on change in V02peak from pre to post 16-week intervention.

      Secondary:

      Evaluate the impact of the GR&H program (standardized combination of aerobic and resistance
      training) on change in cardiorespiratory function, immunology, physical function parameters,
      cognition, balance, and patient-reported outcomes from pre to post 16-week intervention.

      Evaluate changes in all measures annually over the 5 year follow-up period.

      Report on enrollment, recruitment, and attrition.

      Exploratory Objectives

      The investigator's exploratory aims are focused on evaluating the impact of exercise on
      biomarkers: (1) aging - p16INK4a, (2) total leukocyte, lymphocyte (T cells and natural killer
      cells), monocyte and neutrophil counts and T cell proliferation assays, natural killer
      cytotoxicity assays, and cytokine production from stimulated neutrophils and monocytes, and
      (3) circulating pro- and anti-inflammatory cytokines.

      OUTLINE:

      Participants will complete pre-intervention assessments, questionnaires and blood draw at
      week 1 and 2 pre-intervention, followed by a 16-week aerobic and resistance training exercise
      program (intervention). Participants will complete assessments, questionnaires and blood
      draws at week 1 and 2 following the intervention and then again at 6 months and 12 months
      following intervention. Questionnaires only will be administered at year 2, 3,4 and 5
      following intervention.
observational model: Case-Only
time perspective: Prospective
measure: Cardiopulmonary exercise test with NIRS and PWA (vascular function)
time frame: Pre-intervention (weeks 1-2), Post-intervention (weeks 17 or 18), 6 months post-intervention, 12-months post intervention
description: The Cardiopulmonary Exercise Test (CPET) with NIRS and PWA will be used to measure peak oxygen content (VO2peak), tissue oxygen saturation and pulse wave analysis during this symptom-limited exercise test.
measure: Anthropometrics-Height
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
description: Measure Height
measure: Anthropometrics-Weight
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
description: Weight
measure: Anthropometrics-BMI
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
description: Measure BMI
measure: Anthropometrics-Blood Pressure
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
description: Measure blood pressure -- both systolic and diastolic
measure: Anthropometrics-Resting Heart Rate
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post intervention, 12 months post-intervention
description: Measure Resting Heart Rate
measure: Body Composition
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6 months post-intervention, 12 months post-intervention
description: DEXA -- Body Composition will be perfomed using a Hologic (Discovery W) Dual X-ray Absorptiometry (DEXA) located in the EORL. Total body weight-mass (BW) and compositional aspects of lean body mass (LBM), fat tissue mass (FM), and percentage body fat (% BF) will be examined using standard DEXA screening procedures. The BW will be measured using a high grade analytical balance-scale (accuracy ± 10 grams).
measure: Measure of muscle composition -- proportion of body fat to lean muscle mass
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Ultrasound -- LogicView™ software (General Electric Company, Milwaukee, WI, USA) will be used to generate real-time panoramic cross-sectional images of the VL. Three panoramic scans at a gain of 50dB and a depth of 5.0 cm. All image analyses will be completed using Image-J software (version 1.46r, National Institutes of Health, USA) with each image area individually scaled from pixels to centimeters via the straight-line function. The polygon function will be used to determine the CSA of the VL by selecting a region including mostly muscle and minimal surrounding fascia. Greater EI values represent greater fibrous (non-muscular) composition.
measure: Vascular Function
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: XCEL Sphygmacor+USCOM
measure: Resting ECG
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Resting electrocardiogram -- Individual wave/complex/intervals components and overall ECG tracings will be assessed using a 12-lead ECG. The study Cardiologist will review each report individually at baseline prior to the Cardiopulmonary Exercise Test for evidence of overt cardiac dysfunction and will deem the potential study participant appropriate/not appropriate for exercise testing.
measure: Functional Tests
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: 6-minute walk
measure: Functional Tests
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Timed Up and Go
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer DKEFS
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer Digit Span
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer Sequencing
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer HVLT-R
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer TMT
measure: Cognitive Testing
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer NeuroCom balance test
measure: Muscle Strength and Power
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Isokinetic, isometric handgrip tests
measure: Blood Draw
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: 30 mL Blood draw for non-subset group
measure: Satisfaction with GR&H Questionnaire
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Administer Satisfaction with GR&H Questionnaire
measure: Acute exercise bout with blood draw for immune/inflammatory parameters (subset group only)
time frame: Pre-intervention (weeks 1-2), post-intervention (weeks 17 or 18), 6-months post-intervention, 12-months post-intervention
description: Cannulated, 3 blood draws over course of 45 minute visit. 50 mL total collected pre-intervention and post intervention; 30 mL total collected at 6 months and 12 months post-intervention
arm group label: 16-week Exercise Program
description: Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.
intervention type: Behavioral
intervention name: 16-week Exercise Rehabilitation Program for Breast Cancer Survivors
description: Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.
arm group label: 16-week Exercise Program
Blood draw for p16 analysis and immune/inflammatory parameters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Claudio L Battaglini, PhD
role: Principal Investigator
affiliation: UNC Lineberger Comprehensive Cancer Center
last name: Kirsten Nyrop
role: Study Director
affiliation: UNC Lineberger Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor