Clinical trial NCT06323707: The IMPACT Implementation-Effectiveness Trial
Official title: Implementing Physical Activity for Individuals With Cancer During Treatment: The IMPACT Implementation-Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Hamilton Health Sciences Corporation
name: Niagara Health System
First posted: 2024-03-21
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Physical activity level
timeFrame: 16-weeks
measure: Physical activity level
timeFrame: 12-months
measure: Physical activity level
timeFrame: 6-months
Secondary outcomes:
measure: Quality of life
timeFrame: 16-weeks
measure: Quality of life
timeFrame: 6-months
measure: Quality of life
timeFrame: 12-months
measure: Level of exercise knowledge
timeFrame: 16-weeks
measure: Level of exercise knowledge
timeFrame: 6-months
measure: Level of exercise knowledge
timeFrame: 12-months
measure: Health status
timeFrame: 16-weeks
measure: Health status
timeFrame: 6-months
measure: Health status
timeFrame: 12-months
measure: Aerobic capacity
timeFrame: 16-weeks
measure: Aerobic capacity
timeFrame: 6-months
measure: Aerobic capacity
timeFrame: 12-months
measure: Cardiovascular outcomes - Blood pressure
timeFrame: 16-weeks
measure: Cardiovascular outcomes - Blood pressure
timeFrame: 6-months
measure: Cardiovascular outcomes - Blood pressure
timeFrame: 12-months
measure: Cardiovascular outcomes - Heart rate
timeFrame: 16-weeks
measure: Cardiovascular outcomes - Heart rate
timeFrame: 6-months
measure: Cardiovascular outcomes - Heart rate
timeFrame: 12-months
Other outcomes:
Locations:
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: St. Catharines
country: Canada
facility: Walker Family Cancer Centre
state: Ontario
Study officials:
References: