Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study

Overview

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.

Full Title of Study: “The Alberta Cancer Exercise “ACE” Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2021

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).

Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming in their community. The exercise intervention will take place at YMCAs and municipal fitness centres across the province. The 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 a 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Exercise Intervention
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Collaborator
    • University of Calgary
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Margaret L McNeely, PT, PhD, Principal Investigator, University of Alberta
    • Nicole Culos-Reed, PhD, Principal Investigator, University of Calgary
  • Overall Contact(s)
    • Margaret L McNeely, PT, PhD, 1-780-248-1531, mmcneely@ualberta.ca

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