Alberta Cancer Exercise Pilot Randomized Trial
ACE
Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial
1 other identifier
interventional
80
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2014
CompletedFirst Posted
Study publicly available on registry
January 5, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedOctober 16, 2018
April 1, 2018
1.7 years
December 30, 2014
October 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Aerobic Capacity
8 weeks
Health-related Quality of Life
8 weeks
Symptom Assessment
8 weeks
Adherence to exercise
24 weeks
Recruitment rate
18 months
- +3 more secondary outcomes
Other Outcomes (3)
Adverse Events rate
24 weeks
Program Costs
24 months
Body composition
8 weeks
Study Arms (2)
Standard Care
ACTIVE COMPARATORParticipants 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.
Supervised Community-based Exercise
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Within 18 months of a diagnosis of any type of cancer
- Receiving or have received curative cancer treatment (e.g., surgery, chemotherapy, radiation therapy)
- Cleared for unrestricted physical activity by their treating oncologist
You may not qualify if:
- Presence of metastatic disease
- Any uncontrolled or serious comorbid conditions that would preclude participation in exercise testing and training
- Women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- University of Calgarycollaborator
- AHS Cancer Control Albertacollaborator
Study Sites (2)
University of Calgary/ Tom Baker Cancer Centre
Calgary, Alberta, T2N 1N4, Canada
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6J4P9, Canada
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret L McNeely, PhD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 30, 2014
First Posted
January 5, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 30, 2018
Last Updated
October 16, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share
No plan in place