Alberta Cancer Exercise Pilot Randomized Trial (ACE)

Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial

The purpose of the study is to examine the benefit and specific outcomes of a community-based exercise program that is designed to address the needs of individuals who are receiving or recovering from cancer treatment.

Eighty cancer survivors from Edmonton and Calgary will take part in the 24-week long study. Survivors will be randomly assigned to one of two groups. The first group will take part in an 8-week supervised exercise program followed by 8 weeks of self-directed or home-based exercise (early exercise group). The other 40 participants will continue with their normal activities for 16 weeks (delayed exercise group). After the 16 week period, participants in the delayed exercise group will take part in the 8-week supervised exercise program.

Exercise sessions will take place at selected YMCAs in Edmonton and Calgary. Exercise sessions will be supervised by specially trained exercise specialists who have received special training in exercise and cancer.

Outcomes of the study will include feasibility, physical fitness measures, cancer-related symptoms and quality of life.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: Education; Behavioral: Exercise

Detailed Description

Purpose: The primary purpose of this proposed study is to pilot test the planned Alberta Cancer Exercise (ACE) program evaluation components at the level of the individual cancer survivor. These components include program reach as well as effectiveness as determined by outcomes of physical fitness, symptoms, and quality of life. This proposed study will enable us to formalize an evaluation strategy to inform effectiveness and implementation of the ACE program.

Methods: A randomized controlled trial (RCT) design will be utilized to examine the short-term effectiveness of the proposed community-based cancer exercise program designed for cancer survivors. The study will take place at the Cross Cancer Institute/University of Alberta and Tom Baker Cancer Centre/ University of Calgary as well as in selected YMCA community fitness centres in Edmonton and Calgary. The exercise intervention will be delivered by specially trained exercise professionals who have completed the formal cancer exercise education course. Eighty participants will be randomized to early (intervention group) or delayed community-based exercise programming (standard care group). Participants randomized to the intervention group will undertake the ACE Program at a selected Edmonton and Calgary YMCA for an 8-week period. Following the 8-week supervised intervention period, participants will have the option to continue on a 'fee for service' basis or to continue with self-directed exercise at home. Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period. The standard care group will be offered participation in the 8-week ACE program at the completion of the 16-week follow-up period.

Outcomes: The primary outcome is program feasibility: recruitment, completion and adherence rates. For the purposes of the proposed study and the length of follow-up of 24 weeks, the RE-AIM components of Reach, Effectiveness and Implementation at the level of the individual will be evaluated as potential outcome indicators for the ACE program. Outcomes will include measures of health-related physical fitness, cancer-related symptoms and quality of life.

Summary: ACE is an active living initiative, encouraging cancer survivors in Alberta to take a role in their own wellbeing by supporting participation in cancer-specific community-based exercise programs.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary/ Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6J4P9
      • University of Alberta/ Cross Cancer Institute

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Within 18 months of a diagnosis of any type of cancer
2. Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy)
3. Cleared for unrestricted physical activity by their treating oncologist

Exclusion Criteria:

1. Presence of metastatic disease
2. Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training
3. Women who are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants in this group will receive standard education on the importance of physical activity in the recovery from cancer and how to become more active. Participants assigned to this group will have the option to participate in the exercise program after the 16-week follow-up assessment.	Behavioral: Education; Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
Experimental: Supervised Community-based Exercise; Participants in this group will take part in an 8-week supervised exercise program at the YMCA. Following the 8-week intervention, participants will have the option to continue for an additional 8-weeks at the YMCA (fee for service) or follow an 8-week self-directed program.	Behavioral: Education; Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.; Behavioral: Exercise; The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist. Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.; Other Names: Physical Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: number of participants completing the objective outcome measurements for the study	Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic Capacity	Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)	8 weeks
Health-related Quality of Life	Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire	8 weeks
Symptom Assessment	Change in symptoms: Memorial Symptom Assessment Scale	8 weeks
Adherence to exercise	Attendance at supervised exercise sessions	24 weeks
Recruitment rate	Number of participants consenting to the study divided by the number of eligible participants	18 months
Upper Extremity Muscular Strength (optional)	Change in 8 repetition maximum strength of chest press	8 weeks
Upper Extremity Grip Strength (optional)	Hand Grip strength	8 weeks
Lower Extremity Muscular Strength (optional)	Change in 8 repetition maximum strength of leg press	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events rate	Number of serious and minor adverse events	24 weeks
Program Costs	Costs related to study personnel, fitness centre costs and participant related costs	24 months
Body composition	Body mass index	8 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: AHS Cancer Control Alberta; University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HREBA-CC-14-0153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan in place