Clinical trial NCT02330575: Alberta Cancer Exercise Pilot Randomized Trial
Official title: Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: AHS Cancer Control Alberta
First posted: 2015-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: number of participants completing the objective outcome measurements for the study
timeFrame: 24 weeks
Secondary outcomes:
measure: Aerobic Capacity
timeFrame: 8 weeks
measure: Health-related Quality of Life
timeFrame: 8 weeks
measure: Symptom Assessment
timeFrame: 8 weeks
measure: Adherence to exercise
timeFrame: 24 weeks
measure: Recruitment rate
timeFrame: 18 months
measure: Upper Extremity Muscular Strength (optional)
timeFrame: 8 weeks
measure: Upper Extremity Grip Strength (optional)
timeFrame: 8 weeks
measure: Lower Extremity Muscular Strength (optional)
timeFrame: 8 weeks
Other outcomes:
measure: Adverse Events rate
timeFrame: 24 weeks
measure: Program Costs
timeFrame: 24 months
measure: Body composition
timeFrame: 8 weeks
Locations:
city: Calgary
country: Canada
facility: University of Calgary/ Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret L McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: