Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323707
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-06
Brief Title:
The IMPACT Implementation-Effectiveness Trial
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Implementing Physical Activity for Individuals With Cancer During Treatment The IMPACT Implementation-Effectiveness Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
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 ie 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
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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None