<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/NCT03781154</url>
  </required_header>
  <id_info>
    <org_study_id>18-2436.cc</org_study_id>
    <secondary_id>131629-MRSG-18-021- 01-CPPB</secondary_id>
    <nct_id>NCT03781154</nct_id>
  </id_info>
  <brief_title>Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors</brief_title>
  <official_title>Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a two-arm trial, comparing the effects of a virtual 12-week group-based&#xD;
      exercise intervention vs. control group on physical activity, physical fitness, and quality&#xD;
      of life in colorectal cancer survivors, and explore multi-level determinants of physical&#xD;
      activity maintenance, 6-months after intervention completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be prospectively assigned or allocated to either a the exercise&#xD;
      intervention or a control group for 12-weeks. The control group will be provided with an&#xD;
      informational handout from the American Cancer Society describing exercise recommendations&#xD;
      and guidelines for cancer survivors. At the end of the study, control group participants will&#xD;
      be offered compensation for participation in a community-based cancer specific exercise&#xD;
      program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions&#xD;
      will take place twice per week for approximately one hour, and include aerobic, muscular&#xD;
      strength and endurance, balance, and flexibility components. Sessions will be delivered&#xD;
      synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on&#xD;
      the results of baseline fitness assessments and medical history. The intervention will also&#xD;
      include virtual, group-based discussion sessions which operationalize behavior change&#xD;
      techniques to increase physical activity. Discussion sessions will take place in the same&#xD;
      groups, synchronously, via Zoom.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2019</start_date>
  <completion_date type="Actual">June 26, 2023</completion_date>
  <primary_completion_date type="Actual">June 26, 2023</primary_completion_date>
  <phase>Phase 3</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>Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>PI and study staff conducting assessments at study visits will be blinded to study arm assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>From baseline to 12-weeks, and 6 months post intervention</time_frame>
    <description>Compare the effects of a 12-week physical activity intervention delivered in group versus control group, on physical activity. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Fitness: Aerobic</measure>
    <time_frame>From baseline to 12-weeks and 6-months post intervention</time_frame>
    <description>Aerobic fitness will be assessed with a submaximal, graded exercise test on a motorized, calibrated treadmill. Muscular Strength &amp; Endurance will be assessed by multiple repetition maximum (1RM) plate loaded seated bench press and leg press, and by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Fitness: Strength and Endurance</measure>
    <time_frame>From baseline to 12-weeks and 6 months post intervention</time_frame>
    <description>Muscular strength &amp; endurance will be assessed by various weight training activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>From baseline to 12-weeks 6 months post intervention</time_frame>
    <description>Assessed by waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>From baseline to 12 weeks</time_frame>
    <description>Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>From baseline to 12 weeks</time_frame>
    <description>Assessed by a self-report measure of sleep quality using the Pittsburg Sleep Quality Index (PSQI) and through the Actiwatch, which is a wrist-worn monitor that records movement and light exposure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>From baseline to 12 weeks and 6 months post intervention</time_frame>
    <description>Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Group-based exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtually-delivered supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A physical activity education control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Exercise</intervention_name>
    <description>Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change.</description>
    <arm_group_label>Group-based exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision to sign and date the consent form&#xD;
&#xD;
          2. Fluent in English&#xD;
&#xD;
          3. Have access to a computer or phone with internet and a camera&#xD;
&#xD;
          4. Stated willingness to comply with all study procedures and be available for the&#xD;
             duration of the study&#xD;
&#xD;
          5. Be a male or female aged 40 years or older at time of diagnosis&#xD;
&#xD;
          6. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with&#xD;
             curative intent, and no current evidence of metastatic disease&#xD;
&#xD;
          7. Completed resection or other surgery 3-24 months prior to enrollment&#xD;
&#xD;
          8. Received chemotherapy and/or radiation therapy within the previous year, with at least&#xD;
             1 cycle of intended chemotherapy completed (does not need to complete all cycles). No&#xD;
             plans for additional chemotherapy or radiation therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current evidence of metastatic disease&#xD;
&#xD;
          2. Existing participation in ≥150 minutes per week of at least moderate intensity PA&#xD;
&#xD;
          3. Known contraindications for exercise or not able to safely participate in exercise&#xD;
&#xD;
          4. Pregnant women (no testing required)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wells Messersmith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poudre Valley Hospital</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>800524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado State University</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harmony Campus</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Survivors</keyword>
  <keyword>Maintenance</keyword>
  <keyword>Personal Training</keyword>
  <keyword>Group Mediated Cognitive Behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781154
org study id: 18-2436.cc
secondary id: 131629-MRSG-18-021- 01-CPPB
nct id: NCT03781154
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a two-arm trial, comparing the effects of a virtual 12-week group-based
      exercise intervention vs. control group on physical activity, physical fitness, and quality
      of life in colorectal cancer survivors, and explore multi-level determinants of physical
      activity maintenance, 6-months after intervention completion.
Participants will be prospectively assigned or allocated to either a the exercise
      intervention or a control group for 12-weeks. The control group will be provided with an
      informational handout from the American Cancer Society describing exercise recommendations
      and guidelines for cancer survivors. At the end of the study, control group participants will
      be offered compensation for participation in a community-based cancer specific exercise
      program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions
      will take place twice per week for approximately one hour, and include aerobic, muscular
      strength and endurance, balance, and flexibility components. Sessions will be delivered
      synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on
      the results of baseline fitness assessments and medical history. The intervention will also
      include virtual, group-based discussion sessions which operationalize behavior change
      techniques to increase physical activity. Discussion sessions will take place in the same
      groups, synchronously, via Zoom.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: PI and study staff conducting assessments at study visits will be blinded to study arm assignment.
measure: Physical Activity
time frame: From baseline to 12-weeks, and 6 months post intervention
description: Compare the effects of a 12-week physical activity intervention delivered in group versus control group, on physical activity. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer.
measure: Physical Fitness: Aerobic
time frame: From baseline to 12-weeks and 6-months post intervention
description: Aerobic fitness will be assessed with a submaximal, graded exercise test on a motorized, calibrated treadmill. Muscular Strength & Endurance will be assessed by multiple repetition maximum (1RM) plate loaded seated bench press and leg press, and by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.
measure: Physical Fitness: Strength and Endurance
time frame: From baseline to 12-weeks and 6 months post intervention
description: Muscular strength & endurance will be assessed by various weight training activities.
measure: Body Composition
time frame: From baseline to 12-weeks 6 months post intervention
description: Assessed by waist circumference
measure: Body Composition
time frame: From baseline to 12 weeks
description: Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)
measure: Sleep Quality
time frame: From baseline to 12 weeks
description: Assessed by a self-report measure of sleep quality using the Pittsburg Sleep Quality Index (PSQI) and through the Actiwatch, which is a wrist-worn monitor that records movement and light exposure.
measure: Quality of Life Assessment
time frame: From baseline to 12 weeks and 6 months post intervention
description: Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
arm group label: Group-based exercise
arm group type: Experimental
description: Virtually-delivered supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components.
arm group label: Control Group
arm group type: No Intervention
description: A physical activity education control group
intervention type: Behavioral
intervention name: Group Exercise
description: Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change.
arm group label: Group-based exercise
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Wells Messersmith, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No