Alberta Cancer Exercise Pilot Randomized Trial

Neoplasms Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330575
• Other study ID #: HREBA-CC-14-0153
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.
• 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.

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 (3)

Lead Sponsor	Collaborator
University of Alberta	AHS Cancer Control Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events rate	Number of serious and minor adverse events	24 weeks
Other	Program Costs	Costs related to study personnel, fitness centre costs and participant related costs	24 months
Other	Body composition	Body mass index	8 weeks
Primary	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	Aerobic Capacity	Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)	8 weeks
Secondary	Health-related Quality of Life	Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire	8 weeks
Secondary	Symptom Assessment	Change in symptoms: Memorial Symptom Assessment Scale	8 weeks
Secondary	Adherence to exercise	Attendance at supervised exercise sessions	24 weeks
Secondary	Recruitment rate	Number of participants consenting to the study divided by the number of eligible participants	18 months
Secondary	Upper Extremity Muscular Strength (optional)	Change in 8 repetition maximum strength of chest press	8 weeks
Secondary	Upper Extremity Grip Strength (optional)	Hand Grip strength	8 weeks
Secondary	Lower Extremity Muscular Strength (optional)	Change in 8 repetition maximum strength of leg press	8 weeks