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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 : August 30, 2021
Sponsor:
Collaborators:
University of Calgary
Alberta Health Services
Cross Cancer Institute
Tom Baker Cancer Centre
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE December 6, 2016
Last Update Posted Date August 30, 2021
Actual Study Start Date  ICMJE January 9, 2017
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Aerobic Endurance [ Time Frame: Baseline to One-year ]
    Change in 6 minute walk test distance (metres)
  • Quality of Life Cancer Specific [ Time Frame: Baseline to One year ]
    Change in Functional Assessment of Cancer Therapy General Scale
  • General Health-related Quality of Life [ Time Frame: Baseline to One-year ]
    Change in Rand Short Form (SF)-36
  • Fatigue [ Time Frame: Baseline to One-year ]
    FACT-Fatigue subscale
  • Upper extremity grip strength [ Time Frame: Baseline to One-year ]
    Change in hand-grip dynamometry (kg)
  • Functional performance test [ Time Frame: Baseline to One-year ]
    Change in sit-to-stand (number in 30 seconds)
  • Upper extremity flexibility [ Time Frame: Baseline to One-year ]
    Change in active shoulder flexion range of motion (degrees)
  • Lower extremity flexibility [ Time Frame: Baseline to One-year ]
    Change in sit-and-reach test (cm)
  • Balance [ Time Frame: Baseline to One-year ]
    Change in one legged stance test (seconds)
  • Cost-effectiveness evaluation [ Time Frame: Baseline to One-year ]
    EQ-5D questionnaire
  • Exercise adherence [ Time Frame: Baseline to 12-weeks ]
    Adherence to exercise programming (attendance at sessions)
  • Body Composition [ Time Frame: Baseline to One-year ]
    Change in BMI
  • Waist and hip measurements [ Time Frame: Baseline to One-year ]
    Change in waist and hip circumference (cm) and change in waist-to-hip ratio
  • Program implementation and evaluation [ Time Frame: Baseline to One-year ]
    RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
  • Adverse events [ Time Frame: Baseline to One-year ]
    Adverse event rates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 15, 2020)
  • Home-based programming stepping test [ Time Frame: Baseline to One-year ]
    2-minute stepping test
  • 1RM or 8RM strength (optional) [ Time Frame: Baseline to One-year ]
    Change in bench press, vertical row and leg press strength (kg)
  • Muscular endurance test (optional) [ Time Frame: Baseline to One-year ]
    Change in number of push-ups
  • Core endurance test (optional) [ Time Frame: Baseline to One-year ]
    Change in plank test (seconds held)
Original Other Pre-specified Outcome Measures
 (submitted: December 5, 2016)
  • Aerobic Fitness (optional) [ Time Frame: Baseline to One-year ]
    Change in YMCA submaximal cycle ergometer test or Ebbeling submaximal treadmill test (estimated VO2)
  • 1RM or 8RM strength (optional) [ Time Frame: Baselinet to One-year ]
    Change in bench press, vertical row and leg press strength (kg)
  • 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)
  • Core endurance test (optional) [ Time Frame: Baselinet to One-year ]
    Change in plank test (seconds held)
  • Body Composition (optional) [ Time Frame: Baseline to One-year ]
    Change in dual x-ray absorptiometry (DEXA) percent fat and lean tissue mass
 
Descriptive Information
Brief Title  ICMJE Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study
Official Title  ICMJE The Alberta Cancer Exercise "ACE" Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention
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.
Detailed Description

A total of 2500 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). Virtual and supported home-based options will be available as an alternative.

Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming in their home or community. The exercise intervention will take place at the survivor's home, YMCAs and municipal fitness centres across the province. The supported home-based and 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 an 8-to-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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: Exercise
Publications * McNeely ML, Sellar C, Williamson T, Shea-Budgell M, Joy AA, Lau HY, Easaw JC, Murtha AD, Vallance J, Courneya K, Mackey JR, Parliament M, Culos-Reed N. Community-based exercise for health promotion and secondary cancer prevention in Canada: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2019 Sep 13;9(9):e029975. doi: 10.1136/bmjopen-2019-029975.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
2500
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2016)
1000
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Margaret L McNeely, PT, PhD 1-780-248-1531 mmcneely@ualberta.ca
Contact: Christopher Sellar, PhD 1-780-492-6007 csellar@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02984163
Other Study ID Numbers  ICMJE HREBA.CC-16-0905
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No plan in place at this point in time.
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • University of Calgary
  • Alberta Health Services
  • Cross Cancer Institute
  • Tom Baker Cancer Centre
Investigators  ICMJE
Principal Investigator: Margaret L McNeely, PT, PhD University of Alberta
Principal Investigator: Nicole Culos-Reed, PhD University of Calgary
PRS Account University of Alberta
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP