Clinical trial NCT02984163: Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study
Official title: The Alberta Cancer Exercise "ACE" Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: cancer
exercise
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Alberta Health services
name: Cross Cancer Institute
name: Tom Baker Cancer Centre
First posted: 2016-12-06
Enrollment: 2570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. have a diagnosis of cancer;
2. be over the age of 18 years;
3. be able to participate in low-intensity levels of activity at minimum;
4. 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);
5. be able to provide informed written consent in English.

Exclusion criteria:

1) Inability or deemed unsafe to participate in physical activity program

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Primary outcomes:
measure: Physical Activity Minutes Per Week
timeFrame: Baseline to One-year
Secondary outcomes:
measure: Aerobic Endurance
timeFrame: Baseline to One-year
measure: Quality of Life Cancer Specific
timeFrame: Baseline to One year
measure: General Health-related Quality of Life
timeFrame: Baseline to One-year
measure: Fatigue
timeFrame: Baseline to One-year
measure: Upper extremity grip strength
timeFrame: Baseline to One-year
measure: Functional performance test
timeFrame: Baseline to One-year
measure: Upper extremity flexibility
timeFrame: Baseline to One-year
measure: Lower extremity flexibility
timeFrame: Baseline to One-year
measure: Balance
timeFrame: Baseline to One-year
measure: Cost-effectiveness evaluation
timeFrame: Baseline to One-year
measure: Exercise adherence
timeFrame: Baseline to 12-weeks
measure: Body Composition
timeFrame: Baseline to One-year
measure: Waist and hip measurements
timeFrame: Baseline to One-year
measure: Program implementation and evaluation
timeFrame: Baseline to One-year
measure: Adverse events
timeFrame: Baseline to One-year
Other outcomes:
measure: Home-based programming stepping test
timeFrame: Baseline to One-year
measure: 1RM or 8RM strength (optional)
timeFrame: Baseline to One-year
measure: Muscular endurance test (optional)
timeFrame: Baseline to One-year
measure: Core endurance test (optional)
timeFrame: Baseline to One-year
Locations:
city: Calgary
country: Canada
facility: University of Calgary/ Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta & Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret L McNeely, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.