EXCEL: Exercise for Cancer to Enhance Living Well

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Head and Neck Cancer, Colon Cancer, Breast Cancer, Prostate Cancer, Cancer Caregivers

Intervention / Treatment
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* Behavioral: Group Exercise Classes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Hybrid implementation effectiveness study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All participants will be involved in group exercise classes, twice a week for 12 weeks. | Behavioral: Group Exercise Classes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Minutes Per Week | 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. | Baseline to one-year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Physical activity, Exercise, Community programs, Online resources, Cancer survivor, mobile health, telehealth