The IMPACT Implementation-Effectiveness Trial

Официальное название

Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Exercise
  Eight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution.
• Поведенческое Self-management e-module
  Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.

Первичные конечные точки

• Physical activity level [Срок оценки: 16-weeks]
• Physical activity level [Срок оценки: 12-months]
• Physical activity level [Срок оценки: 6-months]

Вторичные конечные точки (12)

• Quality of life [Срок оценки: 16-weeks]
• Quality of life [Срок оценки: 6-months]
• Quality of life [Срок оценки: 12-months]
• Level of exercise knowledge [Срок оценки: 16-weeks]
• Level of exercise knowledge [Срок оценки: 6-months]
• Level of exercise knowledge [Срок оценки: 12-months]
• Health status [Срок оценки: 16-weeks]
• Health status [Срок оценки: 6-months]
• Health status [Срок оценки: 12-months]
• Aerobic capacity [Срок оценки: 16-weeks]
• Aerobic capacity [Срок оценки: 6-months]
• Aerobic capacity [Срок оценки: 12-months]

Критерии участия

Критерии включения

• 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

Критерии исключения

1\) Self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating in moderate intensity exercise

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 3 центра

• Joseph Brant Hospital — Burlington
• Juravinski Cancer Centre — Hamilton
• Walker Family Cancer Centre — St. Catharines

Публикации

• 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

Идентификаторы

NCT: NCT06323707 · IMPACT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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