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EXCEL: Exercise for Cancer to Enhance Living Well (EXCEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04478851
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
University of Alberta
Dalhousie University
Alberta Health services
University Health Network, Toronto
Memorial University of Newfoundland
University of British Columbia
University of Prince Edward Island
Information provided by (Responsible Party):
University of Calgary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Head and Neck Cancer Colon Cancer Breast Cancer Prostate Cancer Cancer Caregivers Behavioral: Group Exercise Classes Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Hybrid implementation effectiveness study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
All participants will be involved in group exercise classes, twice a week for 12 weeks.
Behavioral: Group Exercise Classes
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.




Primary Outcome Measures :
  1. Physical Activity Minutes Per Week [ Time Frame: Baseline to one-year ]
    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.


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in body mass index (BMI)

  2. Aerobic Endurance [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in 6-minute walk test (m) or 2 minute step test (steps) results

  3. Upper extremity grip strength [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in hand-grip dynamometry (kg)

  4. Functional performance test [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in sit-to-stand (number of repetitions in 30 seconds)

  5. Upper extremity flexibility [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in active shoulder flexion range of motion (degrees)

  6. Lower extremity flexibility [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in sit-and-reach test (cm)

  7. Balance [ Time Frame: Baseline to post 12-week exercise intervention ]
    Change in one legged stance test (seconds)

  8. Symptom tracking [ Time Frame: Baseline to one year ]
    Change in fatigue, mood, and QOL, recorded via m-Health app

  9. Cancer related symptoms [ Time Frame: Baseline to one year ]

    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.


  10. Subjective reporting of average weekly physical activity [ Time Frame: Baseline to one year ]
    Change in Godin Leisure Time Exercise Questionnaire

  11. General Health-related Quality of Life [ Time Frame: Baseline to one year ]

    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.


  12. Fatigue [ Time Frame: Baseline to one year ]

    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".


  13. General well-being [ Time Frame: Baseline to one year ]

    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".


  14. Cognition [ Time Frame: Baseline to one year ]

    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).


  15. Barriers and facilitators to exercise participation [ Time Frame: Baseline to one year ]
    Change in Exercise Barriers and Facilitators questionnaire

  16. Exercise adherence [ Time Frame: Baseline to one year ]
    Adherence to exercise programming (attendance at sessions)

  17. Program implementation and evaluation [ Time Frame: Baseline to one year ]
    RE-AIM: program reach, effectiveness, adoption, implementation and maintenance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have a diagnosis of cancer
  • are over the age of 18 years
  • are able to participate in mild levels of activity
  • are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years
  • can read/write in English
  • can access online programs, if necessary, to participate in the exercise programs.

Exclusion Criteria:

  • unable to read/write in English
  • are unable to participate in exercise
  • for online programs, do not have internet or computer access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478851


Contacts
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Contact: Nicole Culos-Reed, PhD +1 (403) 220-7540 nculosre@ucalgary.ca
Contact: Julianna Dreger, M.ClinExPhys +1 (403) 210-8482 jdreger@ucalgary.ca

Locations
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Canada, Alberta
Health and Wellness Lab, University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Nicole Culos-Reed, PhD    +1 403-210-8482    wellnesslab@ucalgary.ca   
Contact: Julianna Dreger, M.ClinExPhys    +1 403-210-8482    wellnesslab@ucalgary.ca   
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Margaret L McNeely, PhD         
Canada, Nova Scotia
Dalhousie University Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 4R2
Contact: Melanie Keats, PhD         
Sponsors and Collaborators
University of Calgary
University of Alberta
Dalhousie University
Alberta Health services
University Health Network, Toronto
Memorial University of Newfoundland
University of British Columbia
University of Prince Edward Island
Investigators
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Principal Investigator: Nicole Culos-Reed, PhD University of Calgary
Principal Investigator: Margaret L McNeely, PhD University of Alberta
Principal Investigator: Melanie Keats, PhD Dalhousie University
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04478851    
Other Study ID Numbers: HREBA.CC-20-0098
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan at this time to share IPD outside of the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Physical activity
Exercise
Community programs
Online resources
Quality of life
Cancer survivor
mobile health
telehealth
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms