EXCEL: Exercise for Cancer to Enhance Living Well

Not Applicable

Recruiting

• Conditions: Colon Cancer; Cancer; Prostate Cancer; Head and Neck Cancer; Breast Cancer; Cancer Caregivers
• Interventions: Behavioral: Group Exercise Classes

• Registration Number: NCT04478851
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-21
• Study Start: 2020-09-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Group Exercise Classes	All participants will be involved in group exercise classes, twice a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Physical Activity Minutes Per Week	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

Name	Time	Method
Upper extremity grip strength	Baseline to post 12-week exercise intervention	Change in hand-grip dynamometry (kg)
Functional performance test	Baseline to post 12-week exercise intervention	Change in sit-to-stand (number of repetitions in 30 seconds)
Upper extremity flexibility	Baseline to post 12-week exercise intervention	Change in active shoulder flexion range of motion (degrees)
Lower extremity flexibility	Baseline to post 12-week exercise intervention	Change in sit-and-reach test (cm)
Balance	Baseline to post 12-week exercise intervention	Change in one legged stance test (seconds)
Symptom tracking	Baseline to one year	Change in fatigue, mood, and QOL, recorded via m-Health app
Cancer related symptoms	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.
Body Composition	Baseline to post 12-week exercise intervention	Change in body mass index (BMI)
Aerobic Endurance	Baseline to post 12-week exercise intervention	Change in 6-minute walk test (m) or 2 minute step test (steps) results
Subjective reporting of average weekly physical activity	Baseline to one year	Change in Godin Leisure Time Exercise Questionnaire
General Health-related Quality of Life	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.
Fatigue	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".
General well-being	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".
Cognition	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).
Barriers and facilitators to exercise participation	Baseline to one year	Change in Exercise Barriers and Facilitators questionnaire
Exercise adherence	Baseline to one year	Adherence to exercise programming (attendance at sessions)
Program implementation and evaluation	Baseline to one year	RE-AIM: program reach, effectiveness, adoption, implementation and maintenance

Trial Locations

Locations (3)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

Health and Wellness Lab, University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada