Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study

Neoplasms Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984163
• Other study ID #: HREBA.CC-16-0905
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: Margaret L McNeely, PT, PhD
• Phone: 1-780-248-1531
• Email: mmcneely[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Exercise
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.

Locations

Country	Name	City	State
Canada	University of Calgary/ Tom Baker Cancer Centre	Calgary	Alberta
Canada	University of Alberta & Cross Cancer Institute	Edmonton	Alberta

Sponsors (5)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services, Cross Cancer Institute, Tom Baker Cancer Centre, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home-based programming stepping test	2-minute stepping test	Baseline to One-year
Other	1RM or 8RM strength (optional)	Change in bench press, vertical row and leg press strength (kg)	Baseline to One-year
Other	Muscular endurance test (optional)	Change in number of push-ups	Baseline to One-year
Other	Core endurance test (optional)	Change in plank test (seconds held)	Baseline to One-year
Primary	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	Aerobic Endurance	Change in 6 minute walk test distance (metres)	Baseline to One-year
Secondary	Quality of Life Cancer Specific	Change in Functional Assessment of Cancer Therapy General Scale	Baseline to One year
Secondary	General Health-related Quality of Life	Change in Rand Short Form (SF)-36	Baseline to One-year
Secondary	Fatigue	FACT-Fatigue subscale	Baseline to One-year
Secondary	Upper extremity grip strength	Change in hand-grip dynamometry (kg)	Baseline to One-year
Secondary	Functional performance test	Change in sit-to-stand (number in 30 seconds)	Baseline to One-year
Secondary	Upper extremity flexibility	Change in active shoulder flexion range of motion (degrees)	Baseline to One-year
Secondary	Lower extremity flexibility	Change in sit-and-reach test (cm)	Baseline to One-year
Secondary	Balance	Change in one legged stance test (seconds)	Baseline to One-year
Secondary	Cost-effectiveness evaluation	EQ-5D questionnaire	Baseline to One-year
Secondary	Exercise adherence	Adherence to exercise programming (attendance at sessions)	Baseline to 12-weeks
Secondary	Body Composition	Change in BMI	Baseline to One-year
Secondary	Waist and hip measurements	Change in waist and hip circumference (cm) and change in waist-to-hip ratio	Baseline to One-year
Secondary	Program implementation and evaluation	RE-AIM: program reach, effectiveness, adoption, implementation and maintenance	Baseline to One-year
Secondary	Adverse events	Adverse event rates	Baseline to One-year