Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study

Not Applicable

Active, not recruiting

• Conditions: Neoplasms
• Interventions: Behavioral: Exercise

• Registration Number: NCT02984163
• Lead Sponsor: University of Alberta

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-06
• Study Start: 2017-01-09
• Primary Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2570

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity Minutes Per Week	Baseline to One-year	Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Calgary/ Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

University of Alberta & Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada