Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study (ACE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret L McNeely, PT, PhD; Phone Number: 1-780-248-1531; Email: mmcneely@ualberta.ca
• Study Contact Backup: Name: Christopher Sellar, PhD; Phone Number: 1-780-492-6007; Email: csellar@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary/ Tom Baker Cancer Centre
      • Contact: Nicole Culos-Reed, PhD; Phone Number: 403-210-8482; Email: wellnesslab@ucalgary.ca
      • Principal Investigator: Nicole Culos-Reed, PhD
    • Edmonton, Alberta, Canada, T6G 2G4
      • Recruiting
      • University of Alberta & Cross Cancer Institute
      • Principal Investigator: Margaret L. McNeely, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Physical Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home-based programming stepping test	2-minute stepping test	Baseline to One-year
1RM or 8RM strength (optional)	Change in bench press, vertical row and leg press strength (kg)	Baseline to One-year
Muscular endurance test (optional)	Change in number of push-ups	Baseline to One-year
Core endurance test (optional)	Change in plank test (seconds held)	Baseline to One-year

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Health services; University of Calgary; Cross Cancer Institute; Tom Baker Cancer Centre
• Investigators: Principal Investigator: Margaret L McNeely, PT, PhD, University of Alberta; Principal Investigator: Nicole Culos-Reed, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: exercise; cancer
• Other Study ID Numbers: HREBA.CC-16-0905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan in place at this point in time.