<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/NCT02984163</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA.CC-16-0905</org_study_id>
    <nct_id>NCT02984163</nct_id>
  </id_info>
  <brief_title>Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study</brief_title>
  <acronym>ACE</acronym>
  <official_title>The Alberta Cancer Exercise &quot;ACE&quot; Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Health services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cross Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tom Baker Cancer Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is&#xD;
      to evaluate the relative benefit from, and implementation of an Alberta wide&#xD;
      clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise&#xD;
      (ACE) Program. The investigators hypothesize that the strategy will improve the physical&#xD;
      well-being and QoL of survivors (on and off cancer treatment) while preventing the&#xD;
      development of secondary cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 2500 adult cancer survivors will be enrolled in the 5-year study. The&#xD;
      investigators will build capacity by expanding ACE training and programming to sites beyond&#xD;
      the large urban centers. The investigators plan for implementation in 7 Alberta YMCAs and/or&#xD;
      City Recreation facilities within 3 years, as well as to formally establish partnerships&#xD;
      within AHS to build further capacity across the province within existing AHS programming&#xD;
      (e.g., CancerControl Rehab Services, Alberta Healthy Living Program and Primary Care&#xD;
      Network). Virtual and supported home-based options will be available as an alternative.&#xD;
&#xD;
      Eligible and consenting participants will be screened for exercise safety, and following&#xD;
      fitness testing will be triaged to appropriate exercise programming in their home or&#xD;
      community. The exercise intervention will take place at the survivor's home, YMCAs and&#xD;
      municipal fitness centres across the province. The supported home-based and community-based&#xD;
      exercise program will be administered by exercise specialists who have undergone the ACE&#xD;
      Cancer and Exercise: Training for Fitness Professionals course. Survivors will take part in a&#xD;
      combination of aerobic, resistance, balance, and flexibility exercises delivered in a&#xD;
      circuit-type class setting or group personal training format, twice weekly for an&#xD;
      8-to-12-week period.&#xD;
&#xD;
      Effectiveness outcomes include physical fitness, physical activity, quality of life, and&#xD;
      healthcare utilization. These outcomes are known factors associated with the secondary&#xD;
      prevention of cancer. The RE-AIM framework will be used to evaluate program reach,&#xD;
      effectiveness, adoption, implementation and maintenance. The Alberta Quality Matrix for&#xD;
      Health will serve as a framework to inform program sustainability beyond the funding period.&#xD;
      Through this research, the investigators will better understand the effectiveness of the ACE&#xD;
      program, and evaluate processes to support future implementation and sustainability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity Minutes Per Week</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aerobic Endurance</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in 6 minute walk test distance (metres)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Cancer Specific</measure>
    <time_frame>Baseline to One year</time_frame>
    <description>Change in Functional Assessment of Cancer Therapy General Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health-related Quality of Life</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in Rand Short Form (SF)-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>FACT-Fatigue subscale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity grip strength</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in hand-grip dynamometry (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional performance test</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in sit-to-stand (number in 30 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity flexibility</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in active shoulder flexion range of motion (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity flexibility</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in sit-and-reach test (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in one legged stance test (seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness evaluation</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence</measure>
    <time_frame>Baseline to 12-weeks</time_frame>
    <description>Adherence to exercise programming (attendance at sessions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist and hip measurements</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in waist and hip circumference (cm) and change in waist-to-hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program implementation and evaluation</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>RE-AIM: program reach, effectiveness, adoption, implementation and maintenance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Adverse event rates</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Home-based programming stepping test</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>2-minute stepping test</description>
  </other_outcome>
  <other_outcome>
    <measure>1RM or 8RM strength (optional)</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in bench press, vertical row and leg press strength (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscular endurance test (optional)</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in number of push-ups</description>
  </other_outcome>
  <other_outcome>
    <measure>Core endurance test (optional)</measure>
    <time_frame>Baseline to One-year</time_frame>
    <description>Change in plank test (seconds held)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant exercise sessions will be conducted in groups of 10-15 under the direct supervision of the community-based exercise specialist. Sessions will be twice a week for 12-weeks. Participants will have the option to continue with the exercise program after the 12-weeks on a fee-for-service basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format.</description>
    <arm_group_label>Exercise Intervention</arm_group_label>
    <other_name>Physical Activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. have a diagnosis of cancer;&#xD;
&#xD;
          2. be over the age of 18 years;&#xD;
&#xD;
          3. be able to participate in low-intensity levels of activity at minimum;&#xD;
&#xD;
          4. be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy&#xD;
             and radiation therapy), or have received cancer treatment within the past 3 years; or&#xD;
             have ongoing significant cancer or treatment-related impairments (requiring supportive&#xD;
             exercise intervention);&#xD;
&#xD;
          5. be able to provide informed written consent in English.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1) Inability or deemed unsafe to participate in physical activity program&#xD;
&#xD;
        -&#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>Margaret L McNeely, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicole Culos-Reed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Margaret L McNeely, PT, PhD</last_name>
    <phone>1-780-248-1531</phone>
    <email>mmcneely@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christopher Sellar, PhD</last_name>
    <phone>1-780-492-6007</phone>
    <email>csellar@ualberta.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Calgary/ Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Culos-Reed, PhD</last_name>
      <phone>403-210-8482</phone>
      <email>wellnesslab@ucalgary.ca</email>
    </contact>
    <investigator>
      <last_name>Nicole Culos-Reed, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Alberta &amp; Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Margaret L. McNeely, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>exercise</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No plan in place at this point in time.</ipd_description>
  </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/NCT02984163
org study id: HREBA.CC-16-0905
nct id: NCT02984163
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is
      to evaluate the relative benefit from, and implementation of an Alberta wide
      clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise
      (ACE) Program. The investigators hypothesize that the strategy will improve the physical
      well-being and QoL of survivors (on and off cancer treatment) while preventing the
      development of secondary cancers.
A total of 2500 adult cancer survivors will be enrolled in the 5-year study. The
      investigators will build capacity by expanding ACE training and programming to sites beyond
      the large urban centers. The investigators plan for implementation in 7 Alberta YMCAs and/or
      City Recreation facilities within 3 years, as well as to formally establish partnerships
      within AHS to build further capacity across the province within existing AHS programming
      (e.g., CancerControl Rehab Services, Alberta Healthy Living Program and Primary Care
      Network). Virtual and supported home-based options will be available as an alternative.

      Eligible and consenting participants will be screened for exercise safety, and following
      fitness testing will be triaged to appropriate exercise programming in their home or
      community. The exercise intervention will take place at the survivor's home, YMCAs and
      municipal fitness centres across the province. The supported home-based and community-based
      exercise program will be administered by exercise specialists who have undergone the ACE
      Cancer and Exercise: Training for Fitness Professionals course. Survivors will take part in a
      combination of aerobic, resistance, balance, and flexibility exercises delivered in a
      circuit-type class setting or group personal training format, twice weekly for an
      8-to-12-week period.

      Effectiveness outcomes include physical fitness, physical activity, quality of life, and
      healthcare utilization. These outcomes are known factors associated with the secondary
      prevention of cancer. The RE-AIM framework will be used to evaluate program reach,
      effectiveness, adoption, implementation and maintenance. The Alberta Quality Matrix for
      Health will serve as a framework to inform program sustainability beyond the funding period.
      Through this research, the investigators will better understand the effectiveness of the ACE
      program, and evaluate processes to support future implementation and sustainability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Physical Activity Minutes Per Week
time frame: Baseline to One-year
description: Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise
measure: Aerobic Endurance
time frame: Baseline to One-year
description: Change in 6 minute walk test distance (metres)
measure: Quality of Life Cancer Specific
time frame: Baseline to One year
description: Change in Functional Assessment of Cancer Therapy General Scale
measure: General Health-related Quality of Life
time frame: Baseline to One-year
description: Change in Rand Short Form (SF)-36
measure: Fatigue
time frame: Baseline to One-year
description: FACT-Fatigue subscale
measure: Upper extremity grip strength
time frame: Baseline to One-year
description: Change in hand-grip dynamometry (kg)
measure: Functional performance test
time frame: Baseline to One-year
description: Change in sit-to-stand (number in 30 seconds)
measure: Upper extremity flexibility
time frame: Baseline to One-year
description: Change in active shoulder flexion range of motion (degrees)
measure: Lower extremity flexibility
time frame: Baseline to One-year
description: Change in sit-and-reach test (cm)
measure: Balance
time frame: Baseline to One-year
description: Change in one legged stance test (seconds)
measure: Cost-effectiveness evaluation
time frame: Baseline to One-year
description: EQ-5D questionnaire
measure: Exercise adherence
time frame: Baseline to 12-weeks
description: Adherence to exercise programming (attendance at sessions)
measure: Body Composition
time frame: Baseline to One-year
description: Change in BMI
measure: Waist and hip measurements
time frame: Baseline to One-year
description: Change in waist and hip circumference (cm) and change in waist-to-hip ratio
measure: Program implementation and evaluation
time frame: Baseline to One-year
description: RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
measure: Adverse events
time frame: Baseline to One-year
description: Adverse event rates
measure: Home-based programming stepping test
time frame: Baseline to One-year
description: 2-minute stepping test
measure: 1RM or 8RM strength (optional)
time frame: Baseline to One-year
description: Change in bench press, vertical row and leg press strength (kg)
measure: Muscular endurance test (optional)
time frame: Baseline to One-year
description: Change in number of push-ups
measure: Core endurance test (optional)
time frame: Baseline to One-year
description: Change in plank test (seconds held)
arm group label: Exercise Intervention
arm group type: Experimental
description: Participant exercise sessions will be conducted in groups of 10-15 under the direct supervision of the community-based exercise specialist. Sessions will be twice a week for 12-weeks. Participants will have the option to continue with the exercise program after the 12-weeks on a fee-for-service basis.
intervention type: Behavioral
intervention name: Exercise
description: Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format.
arm group label: Exercise Intervention
other name: Physical Activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret L McNeely, PT, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Nicole Culos-Reed, PhD
role: Principal Investigator
affiliation: University of Calgary
last name: Margaret L McNeely, PT, PhD
phone: 1-780-248-1531
email: mmcneely@ualberta.ca
last name: Christopher Sellar, PhD
phone: 1-780-492-6007
email: csellar@ualberta.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: No plan in place at this point in time.