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NCT Number: NCT04478851

EXCEL: Exercise for Cancer to Enhance Living Well

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.

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Key information

Conditions

Cancer Behavior Breast Cancer Breast Diseases Breast Neoplasms Cancer Caregivers Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Wellness Lab, University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Exercise Classes

Behavioral

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Julianna Dreger, M.ClinExPhys

CONTACT

[email protected]

+1 (403) 210-8482

Nicole Culos-Reed, PhD

CONTACT

[email protected]

+1 (403) 220-7540

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • Dalhousie University
  • Memorial University of Newfoundland
  • University Health Network, Toronto
  • University of Alberta
  • University of British Columbia
  • University of Prince Edward Island

Registry information

Official study title

Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life

Acronym: EXCEL

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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