<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/NCT02191969</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1324</org_study_id>
    <nct_id>NCT02191969</nct_id>
  </id_info>
  <brief_title>Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer</brief_title>
  <official_title>The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LCCC Geriatric Oncology Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will see if patient who undergo a physical activity intervention called Walk With&#xD;
      Ease report experiencing less fatigue and a higher quality of life during chemotherapy for&#xD;
      colorectal cancer than those who do not participate in this intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this multicenter, randomized controlled study is to evaluate the&#xD;
      impact of a physical activity program on fatigue in older patients (≥60 years) undergoing&#xD;
      adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical&#xD;
      function and quality of life as secondary objectives. The investigators' hypotheses are that&#xD;
      people who undergo the physical activity intervention compared to those who do not, will: 1)&#xD;
      report less fatigue, 2) report higher health related quality of life, and 3) have less&#xD;
      decline in physical function. Additionally, The investigators will characterize ≥grade 3&#xD;
      adjuvant chemotherapy associated toxicities in this older population, and describe the&#xD;
      changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 18, 2019</completion_date>
  <primary_completion_date type="Actual">September 18, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the change in fatigue after three months between the intervention and control arm</measure>
    <time_frame>Three Months</time_frame>
    <description>The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure changes in physical function at baseline between the intervention and control groups.</measure>
    <time_frame>4 to 24 weeks</time_frame>
    <description>To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.&#xD;
• Physical function as measured by PROMIS-PF and SPPB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure adherence to the physical activity intervention</measure>
    <time_frame>One Year</time_frame>
    <description>To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups</measure>
    <time_frame>One Year</time_frame>
    <description>The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms</measure>
    <time_frame>One Year</time_frame>
    <description>The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy</measure>
    <time_frame>Six months</time_frame>
    <description>To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure changes in Quality of Life at baseline between the intervention and control groups.</measure>
    <time_frame>4 to 24 weeks</time_frame>
    <description>To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.&#xD;
Quality of life as measured by FACT-FCSI and PROMIS-PI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure changes in ADLs at baseline between the intervention and control groups.</measure>
    <time_frame>4 to 24 weeks</time_frame>
    <description>To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.&#xD;
ADLs per CGA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.</measure>
    <time_frame>4 to 24 weeks</time_frame>
    <description>To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.&#xD;
IADLs per CGA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure changes in Self-Efficacy at baseline between the intervention and control groups.</measure>
    <time_frame>4 to 24 weeks</time_frame>
    <description>To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.&#xD;
Self-efficacy and attitudes as measured by PSEFSM and OEE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be receiving adjuvant chemotherapy for colorectal cancer. They will not participate in the Walk With Ease program. They will be followed up using standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.&#xD;
Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walk With Ease</intervention_name>
    <description>A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>WWE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ Age 60 years (no upper age limit)&#xD;
&#xD;
          -  Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant&#xD;
             chemotherapy scheduled as part of standard treatment&#xD;
&#xD;
          -  Able to read English (required for CGA and other surveys administered)&#xD;
&#xD;
          -  Approval from their treating physician to engage in moderate-intensity physical&#xD;
             activity&#xD;
&#xD;
          -  Patient-assessed ability to walk and engage in moderate physical activity&#xD;
&#xD;
          -  Signed, IRB-approved written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other active, invasive malignancy requiring ongoing therapy or expected to require&#xD;
             systemic therapy&#xD;
&#xD;
          -  Already walking or engaging in other physical activity &gt;120 minutes per week as&#xD;
             documented via subject self-report&#xD;
&#xD;
          -  Unable to walk or engage in moderate-intensity physical activity&#xD;
&#xD;
          -  One or more significant medical conditions that in the physician's judgment preclude&#xD;
             participation in the walking intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hy Muss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</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>
  <link>
    <url>https://unclineberger.org/patientcare/programs/geriatric</url>
    <description>The Geriatric Oncology Research Program at UNC</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>June 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy</keyword>
  <keyword>Adjuvant Chemotherapy</keyword>
  <keyword>Cancer Therapy</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Physical Function</keyword>
  <keyword>Tiredness</keyword>
  <keyword>Colon Cancer</keyword>
  <keyword>Rectal Cancer</keyword>
  <keyword>Walk With Ease</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Geriatric Assessment</keyword>
  <keyword>Geriatric</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191969
org study id: LCCC1324
nct id: NCT02191969
lead sponsor: 
collaborator: 
has dmc: Yes
This study will see if patient who undergo a physical activity intervention called Walk With
      Ease report experiencing less fatigue and a higher quality of life during chemotherapy for
      colorectal cancer than those who do not participate in this intervention.
The primary purpose of this multicenter, randomized controlled study is to evaluate the
      impact of a physical activity program on fatigue in older patients (≥60 years) undergoing
      adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical
      function and quality of life as secondary objectives. The investigators' hypotheses are that
      people who undergo the physical activity intervention compared to those who do not, will: 1)
      report less fatigue, 2) report higher health related quality of life, and 3) have less
      decline in physical function. Additionally, The investigators will characterize ≥grade 3
      adjuvant chemotherapy associated toxicities in this older population, and describe the
      changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To measure the change in fatigue after three months between the intervention and control arm
time frame: Three Months
description: The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
measure: To measure changes in physical function at baseline between the intervention and control groups.
time frame: 4 to 24 weeks
description: To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
• Physical function as measured by PROMIS-PF and SPPB
measure: To measure adherence to the physical activity intervention
time frame: One Year
description: To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm
measure: To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
time frame: One Year
description: The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
measure: To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
time frame: One Year
description: The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
measure: To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
time frame: Six months
description: To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy.
measure: To measure changes in Quality of Life at baseline between the intervention and control groups.
time frame: 4 to 24 weeks
description: To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
Quality of life as measured by FACT-FCSI and PROMIS-PI
measure: To measure changes in ADLs at baseline between the intervention and control groups.
time frame: 4 to 24 weeks
description: To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
ADLs per CGA
measure: To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
time frame: 4 to 24 weeks
description: To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
IADLs per CGA
measure: To measure changes in Self-Efficacy at baseline between the intervention and control groups.
time frame: 4 to 24 weeks
description: To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
Self-efficacy and attitudes as measured by PSEFSM and OEE
arm group label: Control
arm group type: No Intervention
description: This group will be receiving adjuvant chemotherapy for colorectal cancer. They will not participate in the Walk With Ease program. They will be followed up using standard of care.
arm group label: Intervention
arm group type: Experimental
description: This group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.
Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy.
intervention type: Behavioral
intervention name: Walk With Ease
description: A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.
arm group label: Intervention
other name: WWE
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Hy Muss, MD
role: Principal Investigator
affiliation: UNC Lineberger Comprehensive Cancer Center
facility: 
country: United States
url: https://unclineberger.org/patientcare/programs/geriatric
description: The Geriatric Oncology Research Program at UNC
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Fatigue