CancerPhase 2IMPACTNCT06323707
The IMPACT Implementation-Effectiveness Trial
A Phase 2 study testing Exercise and Self-management e-module in people with Cancer, run by McMaster University at 3 sites in Canada.
Trial summary
More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise and Self-management e-module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Mar 2024to 15 Mar 2027
- Phase
- Phase 2
- 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
- adults with a cancer diagnosis (any type or stage)
- individuals are currently receiving treatment for cancer
- individuals have been cleared for exercise by their oncology care team
Who cannot join
- 1) Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Joseph Brant Hospital
Burlington, Ontario, L7S 0A2
Callista Phillips, MD, (905) 632-3737, cphillips@josephbranthospital.ca
Jenna Smith-Turchyn, PT, PhD, 9058690599, smithjf@mcmaster.ca
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Som D Mukherjee, MD, MSc, 905-387-9495, mukherjee@hhsc.ca
Jenna Smith-Turchyn, PT, PhD, smithjf@mcmaster.ca
- Recruiting
Walker Family Cancer Centre
St. Catharines, Ontario, L2S 0A9
Linda Lee, MD, (905) 682-6451, linda.lee@niagarahealth.on.ca
About this study
Official title: Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial
More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.
What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.
Read more
What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).
In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.
Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario.
Read the detailed description
Rationale:
The burden of cancer in Canada is growing. More individuals are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during active treatment. Institution-based PA services to support wellbeing and minimize burden during treatment are not available across Ontario. Novel implementation strategies are needed within the institution to close the gap between the evidence and clinical practice. Implementation research allows us to understand how to deliver interventions effectively in diverse settings.
Aim \& Objectives:
The overall aim of this project is to conduct a fully powered, multi-centred randomized controlled trial (RCT) to evaluate the effectiveness of a novel implementation strategy including exercise and SM versus usual care for individuals with cancer during treatment. To do this, there are two main objectives: 1) Determine the feasibility and effectiveness of a novel implementation strategy using exercise and SM during treatment
Methods:
Study Design: Effectiveness-Implementation RCT Participants: Adults (>18 years) with a cancer diagnosis of any stage, currently receiving treatment, and cleared for exercise by their oncology care team will be included in this study.
Procedure: Participants will be randomized to three groups. Group 1: Exercise \& SM: Eight sessions of supervised, in-person institution-based exercise and SM education. This group will also receive 4 booster sessions by telephone post intervention.
Group 2: SM Only: Eight virtual sessions of SM education using video conferencing with a qualified exercise professional. This group will also receive 4 booster sessions by phone post intervention.
Group 3: Usual care: No intervention.
Significance:
Implementation research is crucial to improving our understanding of real-world factors that impact successful application of research in healthcare settings. This novel implementation strategy builds off previous work and incorporates institution-based exercise and SM during treatment. Findings from this trial will build off our previous work and inform the way PA services are provided within cancer institutions across Ontario. Our goal is to make these services available to all individuals with cancer during treatment.
- Conditions
- Cancer
- Being tested
- Exercise, Self-management e-module
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Eight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution.
Self-management e-moduleBehavioural
Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Exercise & Self-Management | Experimental | Not described Receives: Behavioral: Exercise; Behavioral: Self-management e-module |
| Self-Management Only | Experimental | Not described Receives: Behavioral: Self-management e-module |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Godin Leisure Time Exercise Questionnaire
Measured: 16-weeks
Physical activity level
Godin Leisure Time Exercise Questionnaire
Measured: 12-months
Physical activity level
Godin Leisure Time Exercise Questionnaire
Measured: 6-months
Secondary outcomes (18)
Quality of life
Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.
Measured: 16-weeks
Quality of life
Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.
Measured: 6-months
Quality of life
Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.
Measured: 12-months
Level of exercise knowledge
Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.
Measured: 16-weeks
Level of exercise knowledge
Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.
Measured: 6-months
Level of exercise knowledge
Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.
Measured: 12-months
Health status
Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.
Measured: 16-weeks
Health status
Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.
Measured: 6-months
Health status
Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.
Measured: 12-months
Aerobic capacity
Six minute walk test
Measured: 16-weeks
Aerobic capacity
Six minute walk test
Measured: 6-months
Aerobic capacity
Six minute walk test
Measured: 12-months
Cardiovascular outcomes - Blood pressure
Resting Blood Pressure
Measured: 16-weeks
Cardiovascular outcomes - Blood pressure
Resting Blood Pressure
Measured: 6-months
Cardiovascular outcomes - Blood pressure
Resting Blood Pressure
Measured: 12-months
Cardiovascular outcomes - Heart rate
Resting heart rate
Measured: 16-weeks
Cardiovascular outcomes - Heart rate
Resting heart rate
Measured: 6-months
Cardiovascular outcomes - Heart rate
Resting heart rate
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 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 CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Hamilton Health Sciences Corporation, Niagara Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323707
- Sponsor's protocol ID
- IMPACT
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith-Turchyn J, Sabiston CM, Edward H, Richardson J, Nayiga BK, Page A, Brooks D, Mukherjee SD. Implementing physical activity for individuals with cancer during treatment: protocol for the IMPACT implementation-effectiveness trial. BMJ Open. 2025 Mar 27;15(3):e101013. doi: 10.1136/bmjopen-2025-101013.
PubMed 40148001
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial
- ClinicalTrials.gov ID
- NCT06323707
- Acronym / sponsor ID
- IMPACT / IMPACT
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Hamilton Health Sciences Corporation, Niagara Health System
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- 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.
More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.
What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.
What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).
In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.
Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario.
Detailed description
Rationale:
The burden of cancer in Canada is growing. More individuals are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during active treatment. Institution-based PA services to support wellbeing and minimize burden during treatment are not available across Ontario. Novel implementation strategies are needed within the institution to close the gap between the evidence and clinical practice. Implementation research allows us to understand how to deliver interventions effectively in diverse settings.
Aim \& Objectives:
The overall aim of this project is to conduct a fully powered, multi-centred randomized controlled trial (RCT) to evaluate the effectiveness of a novel implementation strategy including exercise and SM versus usual care for individuals with cancer during treatment. To do this, there are two main objectives: 1) Determine the feasibility and effectiveness of a novel implementation strategy using exercise and SM during treatment
Methods:
Study Design: Effectiveness-Implementation RCT Participants: Adults (>18 years) with a cancer diagnosis of any stage, currently receiving treatment, and cleared for exercise by their oncology care team will be included in this study.
Procedure: Participants will be randomized to three groups. Group 1: Exercise \& SM: Eight sessions of supervised, in-person institution-based exercise and SM education. This group will also receive 4 booster sessions by telephone post intervention.
Group 2: SM Only: Eight virtual sessions of SM education using video conferencing with a qualified exercise professional. This group will also receive 4 booster sessions by phone post intervention.
Group 3: Usual care: No intervention.
Significance:
Implementation research is crucial to improving our understanding of real-world factors that impact successful application of research in healthcare settings. This novel implementation strategy builds off previous work and incorporates institution-based exercise and SM during treatment. Findings from this trial will build off our previous work and inform the way PA services are provided within cancer institutions across Ontario. Our goal is to make these services available to all individuals with cancer during treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise & Self-Management | Experimental | Behavioral: Exercise, Behavioral: Self-management e-module |
| Self-Management Only | Experimental | Behavioral: Self-management e-module |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with a cancer diagnosis (any type or stage)
- individuals are currently receiving treatment for cancer
- individuals have been cleared for exercise by their oncology care team
Key exclusion criteria (1 listed)
- 1) Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise
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 |
|---|---|---|
| ExerciseEight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution. | Behavioural | Exercise & Self-Management |
| Self-management e-moduleEight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors. | Behavioural | Exercise & Self-Management, Self-Management Only |
Primary outcome
Physical activity level
Time frame: 16-weeks
Godin Leisure Time Exercise Questionnaire
Physical activity level
Time frame: 12-months
Godin Leisure Time Exercise Questionnaire
Physical activity level
Time frame: 6-months
Godin Leisure Time Exercise Questionnaire
18 secondary outcomes
Quality of life
Time frame: 16-weeks
Quality of life
Time frame: 6-months
Quality of life
Time frame: 12-months
Level of exercise knowledge
Time frame: 16-weeks
Level of exercise knowledge
Time frame: 6-months
Level of exercise knowledge
Time frame: 12-months
Health status
Time frame: 16-weeks
Health status
Time frame: 6-months
Health status
Time frame: 12-months
Aerobic capacity
Time frame: 16-weeks
Aerobic capacity
Time frame: 6-months
Aerobic capacity
Time frame: 12-months
Cardiovascular outcomes - Blood pressure
Time frame: 16-weeks
Cardiovascular outcomes - Blood pressure
Time frame: 6-months
Cardiovascular outcomes - Blood pressure
Time frame: 12-months
Cardiovascular outcomes - Heart rate
Time frame: 16-weeks
Cardiovascular outcomes - Heart rate
Time frame: 6-months
Cardiovascular outcomes - Heart rate
Time frame: 12-months
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 16 Oct 2026.
- Derived from this study: PubMed 40148001Smith-Turchyn J, Sabiston CM, Edward H, Richardson J, Nayiga BK, Page A, Brooks D, Mukherjee SD. Implementing physical activity for individuals with cancer during treatment: protocol for the IMPACT implementation-effectiveness trial. BMJ Open. 2025 Mar 27;15(3):e101013. doi: 10.1136/bmjopen-2025-101013.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise and Self-management e-module in people with Cancer, run by McMaster University at 3 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jenna Smith-Turchyn, PT, PhD (905-525-9140, smithjf@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: 16-weeks). The study lists 3 primary outcomes in all. 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 NCT06323707, 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 16 Oct 2026.