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Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study (ACE)

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ClinicalTrials.gov Identifier: NCT02984163
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
University of Calgary
Alberta Health Services
Cross Cancer Institute
Tom Baker Cancer Centre
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is to evaluate the relative benefit from, and implementation of an Alberta wide clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise (ACE) Program. The investigators hypothesize that the strategy will improve the physical well-being and QoL of survivors (on and off cancer treatment) while preventing the development of secondary cancers.

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

Detailed Description:

A total of 1000 adult cancer survivors will be enrolled in the 5-year study. The investigators will build capacity by expanding ACE training and programming to sites beyond the large urban centers. The investigators plan for implementation in 7 Alberta YMCAs and/or City Recreation facilities within 3 years, as well as to formally establish partnerships within AHS to build further capacity across the province within existing AHS programming (e.g., CancerControl Rehab Services, Alberta Healthy Living Program and Primary Care Network).

Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming in their community. The exercise intervention will take place at YMCAs and municipal fitness centres across the province. The community-based exercise program will be administered by exercise specialists who have undergone the ACE Cancer and Exercise: Training for Fitness Professionals course. Survivors will take part in a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period.

Effectiveness outcomes include physical fitness, physical activity, quality of life, and healthcare utilization. These outcomes are known factors associated with the secondary prevention of cancer. The RE-AIM framework will be used to evaluate program reach, effectiveness, adoption, implementation and maintenance. The Alberta Quality Matrix for Health will serve as a framework to inform program sustainability beyond the funding period. Through this research, the investigators will better understand the effectiveness of the ACE program, and evaluate processes to support future implementation and sustainability.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Alberta Cancer Exercise "ACE" Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise Intervention
Participant exercise sessions will be conducted in groups of 10-15 under the direct supervision of the community-based exercise specialist. Sessions will be twice a week for 12-weeks. Participants will have the option to continue with the exercise program after the 12-weeks on a fee-for-service basis.
Behavioral: Exercise
Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format.
Other Name: Physical Activity



Primary Outcome Measures :
  1. Physical Activity Minutes Per Week [ Time Frame: Baseline to One-year ]
    Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise


Secondary Outcome Measures :
  1. Aerobic Endurance [ Time Frame: Baseline to One-year ]
    Change in 6 minute walk test distance (metres)

  2. Quality of Life Cancer Specific [ Time Frame: Baseline to One year ]
    Change in Functional Assessment of Cancer Therapy General Scale

  3. General Health-related Quality of Life [ Time Frame: Baseline to One-year ]
    Change in Rand Short Form (SF)-36

  4. Fatigue [ Time Frame: Baseline to One-year ]
    FACT-Fatigue subscale

  5. Upper extremity grip strength [ Time Frame: Baseline to One-year ]
    Change in hand-grip dynamometry (kg)

  6. Functional performance test [ Time Frame: Baseline to One-year ]
    Change in sit-to-stand (number in 30 seconds)

  7. Upper extremity flexibility [ Time Frame: Baseline to One-year ]
    Change in active shoulder flexion range of motion (degrees)

  8. Lower extremity flexibility [ Time Frame: Baseline to One-year ]
    Change in sit-and-reach test (cm)

  9. Balance [ Time Frame: Baseline to One-year ]
    Change in one legged stance test (seconds)

  10. Cost-effectiveness evaluation [ Time Frame: Baseline to One-year ]
    EQ-5D questionnaire

  11. Exercise adherence [ Time Frame: Baseline to 12-weeks ]
    Adherence to exercise programming (attendance at sessions)

  12. Body Composition [ Time Frame: Baseline to One-year ]
    Change in BMI

  13. Waist and hip measurements [ Time Frame: Baseline to One-year ]
    Change in waist and hip circumference (cm) and change in waist-to-hip ratio

  14. Program implementation and evaluation [ Time Frame: Baseline to One-year ]
    RE-AIM: program reach, effectiveness, adoption, implementation and maintenance

  15. Adverse events [ Time Frame: Baseline to One-year ]
    Adverse event rates


Other Outcome Measures:
  1. Aerobic Fitness (optional) [ Time Frame: Baseline to One-year ]
    Change in YMCA submaximal cycle ergometer test or Ebbeling submaximal treadmill test (estimated VO2)

  2. 1RM or 8RM strength (optional) [ Time Frame: Baselinet to One-year ]
    Change in bench press, vertical row and leg press strength (kg)

  3. Muscular endurance test (optional) [ Time Frame: Baseline to One-year ]
    Change in number of push-ups, seated row endurance test (50% 1RM) or leg press (70% 1RM)

  4. Core endurance test (optional) [ Time Frame: Baselinet to One-year ]
    Change in plank test (seconds held)

  5. Body Composition (optional) [ Time Frame: Baseline to One-year ]
    Change in dual x-ray absorptiometry (DEXA) percent fat and lean tissue mass



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. have a diagnosis of cancer;
  2. be over the age of 18 years;
  3. be able to participate in low-intensity levels of activity at minimum;
  4. be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), or have received cancer treatment within the past 3 years; or have ongoing significant cancer or treatment-related impairments (requiring supportive exercise intervention);
  5. be able to provide informed written consent in English.

Exclusion criteria:

1) Inability or deemed unsafe to participate in physical activity program


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): NCT02984163


Contacts
Contact: Margaret L McNeely, PT, PhD 1-780-248-1531 mmcneely@ualberta.ca
Contact: Christopher Sellar, PhD 1-780-492-6007 csellar@ualberta.ca

Locations
Canada, Alberta
University of Calgary/ Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Nicole Culos-Reed, PhD    403-210-8482    wellnesslab@ucalgary.ca   
Principal Investigator: Nicole Culos-Reed, PhD         
University of Alberta & Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Principal Investigator: Margaret L. McNeely, PhD         
Sponsors and Collaborators
University of Alberta
University of Calgary
Alberta Health Services
Cross Cancer Institute
Tom Baker Cancer Centre
Investigators
Principal Investigator: Margaret L McNeely, PT, PhD University of Alberta
Principal Investigator: Nicole Culos-Reed, PhD University of Calgary

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02984163     History of Changes
Other Study ID Numbers: HREBA.CC-16-0905
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan in place at this point in time.

Keywords provided by University of Alberta:
cancer
exercise