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Completed

NCT Number: NCT02330575

Alberta Cancer Exercise Pilot Randomized 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary/ Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Exercise

Behavioral

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

Education

Behavioral

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

  1. Feasibility: number of participants completing the objective outcome measurements for the study

    Time frame: 24 weeks

    Proportion of subjects completing the physical fitness tests including aerobic capacity, musculoskeletal fitness and body composition measurements.

Secondary outcomes

  1. Aerobic Capacity

    Time frame: 8 weeks

    Change in submaximal aerobic exercise capacity (treadmill, bike or 6 minute walk test)

  2. Health-related Quality of Life

    Time frame: 8 weeks

    Change in quality of life: Functional Assessment of Cancer Therapy General Questionnaire

  3. Symptom Assessment

    Time frame: 8 weeks

    Change in symptoms: Memorial Symptom Assessment Scale

  4. Adherence to exercise

    Time frame: 24 weeks

    Attendance at supervised exercise sessions

  5. Recruitment rate

    Time frame: 18 months

    Number of participants consenting to the study divided by the number of eligible participants

  6. Upper Extremity Muscular Strength (optional)

    Time frame: 8 weeks

    Change in 8 repetition maximum strength of chest press

  7. Upper Extremity Grip Strength (optional)

    Time frame: 8 weeks

    Hand Grip strength

  8. Lower Extremity Muscular Strength (optional)

    Time frame: 8 weeks

    Change in 8 repetition maximum strength of leg press

Other outcomes

  1. Adverse Events rate

    Time frame: 24 weeks

    Number of serious and minor adverse events

  2. Program Costs

    Time frame: 24 months

    Costs related to study personnel, fitness centre costs and participant related costs

  3. Body composition

    Time frame: 8 weeks

    Body mass index

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • AHS Cancer Control Alberta
  • University of Calgary

Registry information

Official study title

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

Acronym: ACE

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jan 5, 2015
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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