Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study

Study Overview
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Brief Summary
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The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is to evaluate the relative benefit from, and implementation of an Alberta wide clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise (ACE) Program. The investigators hypothesize that the strategy will improve the physical well-being and QoL of survivors (on and off cancer treatment) while preventing the development of secondary cancers.

Detailed Description
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A total of 2500 adult cancer survivors will be enrolled in the 5-year study. The investigators will build capacity by expanding ACE training and programming to sites beyond the large urban centers. The investigators plan for implementation in 7 Alberta YMCAs and/or City Recreation facilities within 3 years, as well as to formally establish partnerships within AHS to build further capacity across the province within existing AHS programming (e.g., CancerControl Rehab Services, Alberta Healthy Living Program and Primary Care Network). Virtual and supported home-based options will be available as an alternative. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming in their home or community. The exercise intervention will take place at the survivor's home, YMCAs and municipal fitness centres across the province. The supported home-based and community-based exercise program will be administered by exercise specialists who have undergone the ACE Cancer and Exercise: Training for Fitness Professionals course. Survivors will take part in a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for an 8-to-12-week period. Effectiveness outcomes include physical fitness, physical activity, quality of life, and healthcare utilization. These outcomes are known factors associated with the secondary prevention of cancer. The RE-AIM framework will be used to evaluate program reach, effectiveness, adoption, implementation and maintenance. The Alberta Quality Matrix for Health will serve as a framework to inform program sustainability beyond the funding period. Through this research, the investigators will better understand the effectiveness of the ACE program, and evaluate processes to support future implementation and sustainability.

Official Title
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The Alberta Cancer Exercise ACE Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a diagnosis of cancer; be over the age of 18 years; be able to participate in low-intensity levels of activity at minimum; be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), or have received cancer treatment within the past 3 years; or have ongoing significant cancer or treatment-related impairments (requiring supportive exercise intervention); be able to provide informed written consent in English. Exclusion criteria: 1) Inability or deemed unsafe to participate in physical activity program -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Participant exercise sessions will be conducted in groups of 10-15 under the direct supervision of the community-based exercise specialist. Sessions will be twice a week for 12-weeks. Participants will have the option to continue with the exercise program after the 12-weeks on a fee-for-service basis. | Behavioral: Exercise<br>* Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format.<br>* Other names: Physical Activity;|

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 | Baseline to One-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Endurance | Change in 6 minute walk test distance (metres) | Baseline to One-year | 
| Quality of Life Cancer Specific | Change in Functional Assessment of Cancer Therapy General Scale | Baseline to One year | 
| General Health-related Quality of Life | Change in Rand Short Form (SF)-36 | Baseline to One-year | 
| Fatigue | FACT-Fatigue subscale | Baseline to One-year | 
| Upper extremity grip strength | Change in hand-grip dynamometry (kg) | Baseline to One-year | 
| Functional performance test | Change in sit-to-stand (number in 30 seconds) | Baseline to One-year | 
| Upper extremity flexibility | Change in active shoulder flexion range of motion (degrees) | Baseline to One-year | 
| Lower extremity flexibility | Change in sit-and-reach test (cm) | Baseline to One-year | 
| Balance | Change in one legged stance test (seconds) | Baseline to One-year | 
| Cost-effectiveness evaluation | EQ-5D questionnaire | Baseline to One-year | 
| Exercise adherence | Adherence to exercise programming (attendance at sessions) | Baseline to 12-weeks | 
| Body Composition | Change in BMI | Baseline to One-year | 
| Waist and hip measurements | Change in waist and hip circumference (cm) and change in waist-to-hip ratio | Baseline to One-year | 
| Program implementation and evaluation | RE-AIM: program reach, effectiveness, adoption, implementation and maintenance | Baseline to One-year | 
| Adverse events | Adverse event rates | Baseline to One-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, exercise