<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/NCT04478851</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA.CC-20-0098</org_study_id>
    <nct_id>NCT04478851</nct_id>
  </id_info>
  <brief_title>EXCEL: Exercise for Cancer to Enhance Living Well</brief_title>
  <acronym>EXCEL</acronym>
  <official_title>Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alberta Health services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial University of Newfoundland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</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>
      Project EXCEL will provide community or online exercise programs to rural and remote and&#xD;
      under-served cancer survivors, as well as encourage participants to become life-long&#xD;
      exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer&#xD;
      survivors. However, most cancer survivors who live in remote or rural places don't have&#xD;
      adequate opportunities to be involved in exercise programs that are tailored to their needs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As cancer survivorship numbers grow, a focus on positive health in survivorship is essential.&#xD;
      Exercise is an evidence-based effective self-management strategy that benefits all cancer&#xD;
      survivors (CS). However, the majority of research and the limited development of&#xD;
      evidence-based clinical or community programs in exercise and cancer has been conducted&#xD;
      almost exclusively in urban academic and clinical settings, with very limited implementation&#xD;
      outreach to &quot;hard to reach&quot; CS.&#xD;
&#xD;
      In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years&#xD;
      we will use an integrated knowledge translation approach to move the current evidence-base&#xD;
      that clearly supports the role of exercise in cancer survivorship, into sustainable and&#xD;
      effective community-based or online settings that will optimize the delivery of exercise to&#xD;
      rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise&#xD;
      Oncology Survivorship (EOS) partnership model will result in a sustainable resource to&#xD;
      support the implementation and delivery of exercise oncology programs in rural Canadian&#xD;
      communities.&#xD;
&#xD;
      Investigators will work to develop lasting referral pathways between cancer care clinics and&#xD;
      local fitness professionals. These fitness professionals will have additional cancer specific&#xD;
      training to ensure they can effectively and safely deliver the program. Eligible and&#xD;
      consenting participants will be screened for exercise safety, and following fitness testing&#xD;
      will be triaged to appropriate exercise programming. If, due to COVID-19 public health&#xD;
      restrictions, community based programming cannot occur, the exercise sessions will be&#xD;
      delivered online by fitness professionals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2027</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>
    <intervention_model_description>Hybrid implementation effectiveness study</intervention_model_description>
    <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, based on accelerometer data from commercially-available activity tracker.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Baseline to post 12-week exercise intervention</time_frame>
    <description>Change in body mass index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic Endurance</measure>
    <time_frame>Baseline to post 12-week exercise intervention</time_frame>
    <description>Change in 6-minute walk test (m) or 2 minute step test (steps) results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity grip strength</measure>
    <time_frame>Baseline to post 12-week exercise intervention</time_frame>
    <description>Change in hand-grip dynamometry (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional performance test</measure>
    <time_frame>Baseline to post 12-week exercise intervention</time_frame>
    <description>Change in sit-to-stand (number of repetitions in 30 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity flexibility</measure>
    <time_frame>Baseline to post 12-week exercise intervention</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 post 12-week exercise intervention</time_frame>
    <description>Change in sit-and-reach test (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Baseline to post 12-week exercise intervention</time_frame>
    <description>Change in one legged stance test (seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom tracking</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in fatigue, mood, and QOL, recorded via m-Health app</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer related symptoms</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Edmonton Symptom Assessment Scale.&#xD;
- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective reporting of average weekly physical activity</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Godin Leisure Time Exercise Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Health-related Quality of Life</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in EuroQual - 5Dimensions (EQ-5D) tool&#xD;
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale&#xD;
- scale is from 0-4, where 0 means &quot;not at all&quot; and 4 means &quot;very much&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General well-being</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Functional Assessment of Cancer Therapy - General subscale&#xD;
- scale is from 0-4, where 0 means &quot;not at all&quot; and 4 means &quot;very much&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Functional Assessment of Cancer Therapy - Cognitive subscale&#xD;
- scale is from 0-4, where 0 means &quot;never&quot; and 4 means &quot;several times a day&quot; (experiencing symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers and facilitators to exercise participation</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Change in Exercise Barriers and Facilitators questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence</measure>
    <time_frame>Baseline to one year</time_frame>
    <description>Adherence to exercise programming (attendance at sessions)</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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Colon Cancer</condition>
  <condition>Breast Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Cancer Caregivers</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be involved in group exercise classes, twice a week for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Exercise Classes</intervention_name>
    <description>The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a diagnosis of cancer&#xD;
&#xD;
          -  are over the age of 18 years&#xD;
&#xD;
          -  are able to participate in mild levels of activity&#xD;
&#xD;
          -  are about to have treatment, are currently having treatment, or have had cancer&#xD;
             treatment within the last 5 years&#xD;
&#xD;
          -  can read/write in English&#xD;
&#xD;
          -  can access online programs, if necessary, to participate in the exercise programs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to read/write in English&#xD;
&#xD;
          -  are unable to participate in exercise&#xD;
&#xD;
          -  for online programs, do not have internet or computer access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Culos-Reed, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Margaret L McNeely, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melanie Keats, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Culos-Reed, PhD</last_name>
    <phone>+1 (403) 220-7540</phone>
    <email>nculosre@ucalgary.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julianna Dreger, M.ClinExPhys</last_name>
    <phone>+1 (403) 210-8482</phone>
    <email>jdreger@ucalgary.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Health and Wellness Lab, University of Calgary</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>+1 403-210-8482</phone>
      <email>wellnesslab@ucalgary.ca</email>
    </contact>
    <contact_backup>
      <last_name>Julianna Dreger, M.ClinExPhys</last_name>
      <phone>+1 403-210-8482</phone>
      <email>wellnesslab@ucalgary.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Margaret L McNeely, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 4R2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Melanie Keats, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Exercise</keyword>
  <keyword>Community programs</keyword>
  <keyword>Online resources</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cancer survivor</keyword>
  <keyword>mobile health</keyword>
  <keyword>telehealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan at this time to share IPD outside of the research team.</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/NCT04478851
org study id: HREBA.CC-20-0098
nct id: NCT04478851
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Project EXCEL will provide community or online exercise programs to rural and remote and
      under-served cancer survivors, as well as encourage participants to become life-long
      exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer
      survivors. However, most cancer survivors who live in remote or rural places don't have
      adequate opportunities to be involved in exercise programs that are tailored to their needs.
As cancer survivorship numbers grow, a focus on positive health in survivorship is essential.
      Exercise is an evidence-based effective self-management strategy that benefits all cancer
      survivors (CS). However, the majority of research and the limited development of
      evidence-based clinical or community programs in exercise and cancer has been conducted
      almost exclusively in urban academic and clinical settings, with very limited implementation
      outreach to "hard to reach" CS.

      In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years
      we will use an integrated knowledge translation approach to move the current evidence-base
      that clearly supports the role of exercise in cancer survivorship, into sustainable and
      effective community-based or online settings that will optimize the delivery of exercise to
      rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise
      Oncology Survivorship (EOS) partnership model will result in a sustainable resource to
      support the implementation and delivery of exercise oncology programs in rural Canadian
      communities.

      Investigators will work to develop lasting referral pathways between cancer care clinics and
      local fitness professionals. These fitness professionals will have additional cancer specific
      training to ensure they can effectively and safely deliver the program. Eligible and
      consenting participants will be screened for exercise safety, and following fitness testing
      will be triaged to appropriate exercise programming. If, due to COVID-19 public health
      restrictions, community based programming cannot occur, the exercise sessions will be
      delivered online by fitness professionals.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Hybrid implementation effectiveness study
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, based on accelerometer data from commercially-available activity tracker.
measure: Body Composition
time frame: Baseline to post 12-week exercise intervention
description: Change in body mass index (BMI)
measure: Aerobic Endurance
time frame: Baseline to post 12-week exercise intervention
description: Change in 6-minute walk test (m) or 2 minute step test (steps) results
measure: Upper extremity grip strength
time frame: Baseline to post 12-week exercise intervention
description: Change in hand-grip dynamometry (kg)
measure: Functional performance test
time frame: Baseline to post 12-week exercise intervention
description: Change in sit-to-stand (number of repetitions in 30 seconds)
measure: Upper extremity flexibility
time frame: Baseline to post 12-week exercise intervention
description: Change in active shoulder flexion range of motion (degrees)
measure: Lower extremity flexibility
time frame: Baseline to post 12-week exercise intervention
description: Change in sit-and-reach test (cm)
measure: Balance
time frame: Baseline to post 12-week exercise intervention
description: Change in one legged stance test (seconds)
measure: Symptom tracking
time frame: Baseline to one year
description: Change in fatigue, mood, and QOL, recorded via m-Health app
measure: Cancer related symptoms
time frame: Baseline to one year
description: Change in Edmonton Symptom Assessment Scale.
- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.
measure: Subjective reporting of average weekly physical activity
time frame: Baseline to one year
description: Change in Godin Leisure Time Exercise Questionnaire
measure: General Health-related Quality of Life
time frame: Baseline to one year
description: Change in EuroQual - 5Dimensions (EQ-5D) tool
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
measure: Fatigue
time frame: Baseline to one year
description: Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
measure: General well-being
time frame: Baseline to one year
description: Change in Functional Assessment of Cancer Therapy - General subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
measure: Cognition
time frame: Baseline to one year
description: Change in Functional Assessment of Cancer Therapy - Cognitive subscale
- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).
measure: Barriers and facilitators to exercise participation
time frame: Baseline to one year
description: Change in Exercise Barriers and Facilitators questionnaire
measure: Exercise adherence
time frame: Baseline to one year
description: Adherence to exercise programming (attendance at sessions)
measure: Program implementation and evaluation
time frame: Baseline to one year
description: RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
arm group label: Intervention
arm group type: Experimental
description: All participants will be involved in group exercise classes, twice a week for 12 weeks.
intervention type: Behavioral
intervention name: Group Exercise Classes
description: The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicole Culos-Reed, PhD
role: Principal Investigator
affiliation: University of Calgary
last name: Margaret L McNeely, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Melanie Keats, PhD
role: Principal Investigator
affiliation: Dalhousie University
last name: Nicole Culos-Reed, PhD
phone: +1 (403) 220-7540
email: nculosre@ucalgary.ca
last name: Julianna Dreger, M.ClinExPhys
phone: +1 (403) 210-8482
email: jdreger@ucalgary.ca
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No
ipd description: No plan at this time to share IPD outside of the research team.