NCT06323707 The IMPACT Implementation-Effectiveness Trial
| NCT ID | NCT06323707 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | McMaster University |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 129 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 129 participants in total. It began in 2024-03-15 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. adults with a cancer diagnosis (any type or stage) 2. individuals are currently receiving treatment for cancer 3. individuals have been cleared for exercise by their oncology care team Exclusion Criteria: 1\) Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06323707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06323707 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06323707 currently recruiting?
Yes, NCT06323707 is actively recruiting participants. Contact the research team at smithjf@mcmaster.ca for enrollment information.
Where is the NCT06323707 trial being conducted?
This trial is being conducted at Burlington, Canada, Hamilton, Canada, St. Catharines, Canada.
Who is sponsoring the NCT06323707 clinical trial?
NCT06323707 is sponsored by McMaster University. The trial plans to enroll 129 participants.
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