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Alberta Cancer Exercise Pilot Randomized Trial (ACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330575
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
University of Calgary
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Margie McNeely, University of Alberta

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.


Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Exercise Behavioral: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alberta Cancer Exercise Community-based Program: A Pilot Randomized Controlled Trial
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Care
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.
Behavioral: 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: Supervised Community-based Exercise
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.
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.
Other Name: Physical Activity

Behavioral: 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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330575


Locations
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Canada, Alberta
University of Calgary/ Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 1N4
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada, T6J4P9
Sponsors and Collaborators
University of Alberta
University of Calgary
AHS Cancer Control Alberta
Investigators
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Principal Investigator: Margaret L McNeely, PhD University of Alberta

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Responsible Party: Margie McNeely, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02330575    
Other Study ID Numbers: HREBA-CC-14-0153
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan in place