<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/NCT03750981</url>
  </required_header>
  <id_info>
    <org_study_id>2018-091</org_study_id>
    <nct_id>NCT03750981</nct_id>
  </id_info>
  <brief_title>C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)</brief_title>
  <acronym>CAPABLE</acronym>
  <official_title>Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Pilot Study of Cross-Training in Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barbara Ann Karmanos Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barbara Ann Karmanos Cancer Institute</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>
      This study will introduce cancer survivors to cross-training with the expectation that the&#xD;
      program proposed will ultimately result in superior improvements in functional performance,&#xD;
      body composition and quality of life compared with the current American Cancer Society (ACS)&#xD;
      guidelines for cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 12-week pilot intervention study introducing a high-intensity functional training program&#xD;
      to 100 cancer survivors and evaluate the effects of this program on patient quality of life,&#xD;
      functional capacity, and body composition. Response rates will be determined using various&#xD;
      recruitment methods and estimate differences in response rates by patient characteristics&#xD;
      including race, gender and age. Barriers to participation in the program in contacted&#xD;
      patients who do not enroll as well as patients who enroll and do not complete the program&#xD;
      will be described, as will participant satisfaction with enrolled participants who complete&#xD;
      the program. The goal of this pilot study is to help refine the recruitment and program&#xD;
      methods for a larger intervention study to test the superiority of a high-intensity interval&#xD;
      functional training program compared with current American Cancer Society guidelines in&#xD;
      improving functional capacity, body composition and patient reported quality of life.&#xD;
&#xD;
      Surveys will be completed by each participant weekly and physical assessments will be&#xD;
      completed monthly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment rates</measure>
    <time_frame>Baseline</time_frame>
    <description>Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in weight in kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in body fat percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in visceral fat percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in muscle mass percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Changes in resting metabolism value</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Motivation</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Motivation to exercise will be collected via a survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with the Program</measure>
    <time_frame>12 weeks</time_frame>
    <description>Satisfaction with the program will be collected via a survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
    <description>Height will be collected in meters to use in the calculation of Body Mass Index</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cancer Survivors</condition>
  <arm_group>
    <arm_group_label>A 12-week pilot intervention study introducing a high-intensi</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>12 week pilot intervention study.</intervention_name>
    <description>Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.</description>
    <arm_group_label>A 12-week pilot intervention study introducing a high-intensi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older at time of program recruitment&#xD;
&#xD;
          -  Diagnosed with an invasive cancer&#xD;
&#xD;
          -  Cleared from their physician to participate in the program (We assume that most&#xD;
             patients will have completed treatment, however if a patient is currently under&#xD;
             treatment, this should be their oncologist. If the patient is not currently undergoing&#xD;
             treatment, this could be primary care physician or oncologist).&#xD;
&#xD;
          -  Available transportation to and from the facility on session days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Beebe-Dimmer, MPH, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barbara Ann Karmanos Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer B Beebe-Dimmer, MPH, PhD.</last_name>
    <phone>(313) 578-4209</phone>
    <email>dimmerj@karmanos.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tara Baird, M.Ed.</last_name>
    <phone>(313) 578-4246</phone>
    <email>bairdt@karmanos.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tara Baird</last_name>
      <phone>313-578-4246</phone>
      <email>bairdt@karmanos.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barbara Ann Karmanos Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jennifer Beebe-Dimmer, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03750981
org study id: 2018-091
nct id: NCT03750981
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will introduce cancer survivors to cross-training with the expectation that the
      program proposed will ultimately result in superior improvements in functional performance,
      body composition and quality of life compared with the current American Cancer Society (ACS)
      guidelines for cancer survivors.
A 12-week pilot intervention study introducing a high-intensity functional training program
      to 100 cancer survivors and evaluate the effects of this program on patient quality of life,
      functional capacity, and body composition. Response rates will be determined using various
      recruitment methods and estimate differences in response rates by patient characteristics
      including race, gender and age. Barriers to participation in the program in contacted
      patients who do not enroll as well as patients who enroll and do not complete the program
      will be described, as will participant satisfaction with enrolled participants who complete
      the program. The goal of this pilot study is to help refine the recruitment and program
      methods for a larger intervention study to test the superiority of a high-intensity interval
      functional training program compared with current American Cancer Society guidelines in
      improving functional capacity, body composition and patient reported quality of life.

      Surveys will be completed by each participant weekly and physical assessments will be
      completed monthly.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Enrollment rates
time frame: Baseline
description: Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
time frame: Baseline to 12 weeks
description: Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
time frame: Baseline to 12 weeks
description: Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
time frame: Baseline to 12 weeks
description: Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.
measure: Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire
time frame: Baseline to 12 weeks
description: Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in weight in kg
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in body fat percentage
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in visceral fat percentage
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in muscle mass percentage
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2
measure: Change in Body Composition
time frame: Baseline to 12 weeks
description: Changes in resting metabolism value
measure: Change in Motivation
time frame: Baseline to 12 weeks
description: Motivation to exercise will be collected via a survey
measure: Satisfaction with the Program
time frame: 12 weeks
description: Satisfaction with the program will be collected via a survey
measure: Program Adherence
time frame: 12 weeks
description: Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.
measure: Height
time frame: Baseline
description: Height will be collected in meters to use in the calculation of Body Mass Index
arm group label: A 12-week pilot intervention study introducing a high-intensi
arm group type: Other
intervention type: Behavioral
intervention name: 12 week pilot intervention study.
description: Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.
arm group label: A 12-week pilot intervention study introducing a high-intensi
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Beebe-Dimmer, MPH, PhD.
role: Principal Investigator
affiliation: Barbara Ann Karmanos Cancer Institute
last name: Jennifer B Beebe-Dimmer, MPH, PhD.
phone: (313) 578-4209
email: dimmerj@karmanos.org
last name: Tara Baird, M.Ed.
phone: (313) 578-4246
email: bairdt@karmanos.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Barbara Ann Karmanos Cancer Institute
investigator full name: Jennifer Beebe-Dimmer, PhD
investigator title: Principal Investigator
sharing ipd: No