Alberta Cancer Exercise Pilot Randomized Trial

Study Overview
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Brief Summary
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The purpose of the study is to examine the benefit and specific outcomes of a community-based exercise program that is designed to address the needs of individuals who are receiving or recovering from cancer treatment. Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study. Survivors will be randomly assigned to one of two groups. The first group will take part in an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based exercise (early exercise group). The other 40 participants will continue with their normal activities for 16 weeks (delayed exercise group). After the 16 week period, participants in the delayed exercise group will take part in the 8-week supervised exercise program. Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise sessions will be supervised by specially trained exercise specialists who have received special training in exercise and cancer. Outcomes of the study will include feasibility, physical fitness measures, cancer-related symptoms and quality of life.

Detailed Description
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Purpose: The primary purpose of this proposed study is to pilot test the planned Alberta Cancer Exercise (ACE) program evaluation components at the level of the individual cancer survivor. These components include program reach as well as effectiveness as determined by outcomes of physical fitness, symptoms, and quality of life. This proposed study will enable us to formalize an evaluation strategy to inform effectiveness and implementation of the ACE program. Methods: A randomized controlled trial (RCT) design will be utilized to examine the short-term effectiveness of the proposed community-based cancer exercise program designed for cancer survivors. The study will take place at the Cross Cancer Institute/University of Alberta and Tom Baker Cancer Centre/ University of Calgary as well as in selected YMCA community fitness centres in Edmonton and Calgary. The exercise intervention will be delivered by specially trained exercise professionals who have completed the formal cancer exercise education course. Eighty participants will be randomized to early (intervention group) or delayed community-based exercise programming (standard care group). Participants randomized to the intervention group will undertake the ACE Program at a selected Edmonton and Calgary YMCA for an 8-week period. Following the 8-week supervised intervention period, participants will have the option to continue on a 'fee for service' basis or to continue with self-directed exercise at home. Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period. The standard care group will be offered participation in the 8-week ACE program at the completion of the 16-week follow-up period. Outcomes: The primary outcome is program feasibility: recruitment, completion and adherence rates. For the purposes of the proposed study and the length of follow-up of 24 weeks, the RE-AIM components of Reach, Effectiveness and Implementation at the level of the individual will be evaluated as potential outcome indicators for the ACE program. Outcomes will include measures of health-related physical fitness, cancer-related symptoms and quality of life. Summary: ACE is an active living initiative, encouraging cancer survivors in Alberta to take a role in their own wellbeing by supporting participation in cancer-specific community-based exercise programs.

Official Title
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Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within 18 months of a diagnosis of any type of cancer Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy) Cleared for unrestricted physical activity by their treating oncologist Exclusion Criteria: Presence of metastatic disease Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training Women who are pregnant

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Participants in this group will receive standard education on the importance of physical activity in the recovery from cancer and how to become more active. Participants assigned to this group will have the option to participate in the exercise program after the 16-week follow-up assessment. | Behavioral: Education<br>* Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.<br>|
| Experimental: Supervised Community-based Exercise<br>Participants in this group will take part in an 8-week supervised exercise program at the YMCA. Following the 8-week intervention, participants will have the option to continue for an additional 8-weeks at the YMCA (fee for service) or follow an 8-week self-directed program. | Behavioral: Exercise<br>* The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist. Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.<br>* Other names: Physical Activity;Behavioral: Education<br>* Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: number of participants completing the objective outcome measurements for the study | Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Capacity | Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test) | 8 weeks | 
| Health-related Quality of Life | Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire | 8 weeks | 
| Symptom Assessment | Change in symptoms: Memorial Symptom Assessment Scale | 8 weeks | 
| Adherence to exercise | Attendance at supervised exercise sessions | 24 weeks | 
| Recruitment rate | Number of participants consenting to the study divided by the number of eligible participants | 18 months | 
| Upper Extremity Muscular Strength (optional) | Change in 8 repetition maximum strength of chest press | 8 weeks | 
| Upper Extremity Grip Strength (optional) | Hand Grip strength | 8 weeks | 
| Lower Extremity Muscular Strength (optional) | Change in 8 repetition maximum strength of leg press | 8 weeks |