NeoplasmsACENCT02984163
Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study
A study testing Exercise in people with Neoplasms, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,570 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Jan 2017to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of cancer;
- be over the age of 18 years;
- be able to participate in low-intensity levels of activity at minimum;
- 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);
- be able to provide informed written consent in English.
Who cannot join
- 1) Inability or deemed unsafe to participate in physical activity program
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary/ Tom Baker Cancer Centre
Calgary, Alberta, T2N 1N4
University of Alberta & Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
About this study
Official title: The Alberta Cancer Exercise "ACE" Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Exercise
- Keywords
- cancer, exercise
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Physical Activity
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Minutes Per Week
Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise
Measured: Baseline to One-year
Secondary outcomes (15)
Aerobic Endurance
Change in 6 minute walk test distance (metres)
Measured: Baseline to One-year
Quality of Life Cancer Specific
Change in Functional Assessment of Cancer Therapy General Scale
Measured: Baseline to One year
General Health-related Quality of Life
Change in Rand Short Form (SF)-36
Measured: Baseline to One-year
Fatigue
FACT-Fatigue subscale
Measured: Baseline to One-year
Upper extremity grip strength
Change in hand-grip dynamometry (kg)
Measured: Baseline to One-year
Functional performance test
Change in sit-to-stand (number in 30 seconds)
Measured: Baseline to One-year
Upper extremity flexibility
Change in active shoulder flexion range of motion (degrees)
Measured: Baseline to One-year
Lower extremity flexibility
Change in sit-and-reach test (cm)
Measured: Baseline to One-year
Balance
Change in one legged stance test (seconds)
Measured: Baseline to One-year
Cost-effectiveness evaluation
EQ-5D questionnaire
Measured: Baseline to One-year
Exercise adherence
Adherence to exercise programming (attendance at sessions)
Measured: Baseline to 12-weeks
Body Composition
Change in BMI
Measured: Baseline to One-year
Waist and hip measurements
Change in waist and hip circumference (cm) and change in waist-to-hip ratio
Measured: Baseline to One-year
Program implementation and evaluation
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Measured: Baseline to One-year
Adverse events
Adverse event rates
Measured: Baseline to One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start9 Jan 2017
- Primary completion30 Sep 2024
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Alberta Health services, Cross Cancer Institute, Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Margaret L McNeely, PT, PhD, Principal investigator, University of AlbertaNicole Culos-Reed, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984163
- Sponsor's protocol ID
- HREBA.CC-16-0905
- Acronym
- ACE
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2016
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No plan in place at this point in time.
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.
PubMed 31519676
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alberta Cancer Exercise "ACE" Program for Cancer Survivors: Supporting Community-based Exercise Participation for Health Promotion and Secondary Cancer Prevention
- ClinicalTrials.gov ID
- NCT02984163
- Acronym / sponsor ID
- ACE / HREBA.CC-16-0905
- Conditions
- Neoplasms
- Keywords
- cancer, exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,570 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, Alberta Health services, Cross Cancer Institute, Tom Baker Cancer Centre
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: ExerciseParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a diagnosis of cancer;
- be over the age of 18 years;
- be able to participate in low-intensity levels of activity at minimum;
- 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);
- be able to provide informed written consent in English.
Key exclusion criteria (2 listed)
- 1) Inability or deemed unsafe to participate in physical activity program
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Physical ActivityExercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format. | Behavioural | Exercise Intervention |
Primary outcome
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
15 secondary outcomes
Aerobic Endurance
Time frame: Baseline to One-year
Quality of Life Cancer Specific
Time frame: Baseline to One year
General Health-related Quality of Life
Time frame: Baseline to One-year
Fatigue
Time frame: Baseline to One-year
Upper extremity grip strength
Time frame: Baseline to One-year
Functional performance test
Time frame: Baseline to One-year
Upper extremity flexibility
Time frame: Baseline to One-year
Lower extremity flexibility
Time frame: Baseline to One-year
Balance
Time frame: Baseline to One-year
Cost-effectiveness evaluation
Time frame: Baseline to One-year
Exercise adherence
Time frame: Baseline to 12-weeks
Body Composition
Time frame: Baseline to One-year
Waist and hip measurements
Time frame: Baseline to One-year
Program implementation and evaluation
Time frame: Baseline to One-year
Adverse events
Time frame: Baseline to One-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 31519676McNeely 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.
- Individual participant dataSharing planned: Undecided. No plan in place at this point in time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret L McNeely, PT, PhD principal investigator
University of Alberta
Nicole Culos-Reed, PhD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Neoplasms, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Minutes Per Week (time frame: Baseline to One-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.