The IMPACT Implementation-Effectiveness Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Self-management e-module.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial
Overview
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.
Interventions
- Behavioral Exercise
Eight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution. - Behavioral Self-management e-module
Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.
Primary outcome measures
- Physical activity level [Time frame: 16-weeks]
- Physical activity level [Time frame: 12-months]
- Physical activity level [Time frame: 6-months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
1\) Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Canada · 3 centers
- Joseph Brant Hospital — Burlington
- Juravinski Cancer Centre — Hamilton
- Walker Family Cancer Centre — St. Catharines
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. PMID 40148001
Identifiers
NCT: NCT06323707 · IMPACT