Overview

This trial is active, not recruiting.

Condition neoplasms
Treatments exercise, education
Phase phase 1/phase 2
Sponsor University of Alberta
Collaborator University of Calgary
Start date April 2015
End date December 2016
Trial size 80 participants
Trial identifier NCT02330575, HREBA-CC-14-0153

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
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)
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.
exercise Physical Activity
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.

Primary Outcomes

Measure
Feasibility: number of participants completing the objective outcome measurements for the study
time frame: 24 weeks

Secondary Outcomes

Measure
Aerobic Capacity
time frame: 8 weeks
Quality of Life
time frame: 8 weeks
Symptom Assessment
time frame: 8 weeks
Adherence to exercise
time frame: 24 weeks
Recruitment rate
time frame: 18 months
Upper Extremity Muscular Strength
time frame: 8 weeks
Upper Extremity Grip Strength
time frame: 8 weeks
Lower Extremity Muscular Strength
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial
Principal investigator Margaret L McNeely, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Alberta.