The IMPACT Implementation-Effectiveness Trial (IMPACT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Self-management e-module

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.

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jenna Smith-Turchyn, PT, PhD; Phone Number: 905-525-9140; Email: smithjf@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Community-dwelling
• English-speaking adults
• Aged over 18 years of age
• Currently undergoing adjuvant or neoadjuvant chemotherapy, radiation, or hormonal therapy for cancer
• Cleared by their oncologist to participate in moderate intensity aerobic exercise.

Exclusion Criteria:

• Self-report on the patient intake form any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Exercise & Self-Management	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.
Experimental: Self-Management Only	Behavioral: Self-management e-module; Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Godin Leisure Time Exercise Questionnaire	16-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Godin Leisure Time Exercise Questionnaire	6-months
Physical activity level	Godin Leisure Time Exercise Questionnaire	12-months
Quality of life	Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.	16-weeks
Quality of life	Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.	6-months
Quality of life	Measured using the Functional Assessment of Cancer Therapy-General (FACT-G). Total scores range from 0-108 with higher scores representing higher quality of life.	12-months
Level of exercise knowledge	Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.	16-weeks
Level of exercise knowledge	Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.	6-months
Level of exercise knowledge	Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.	12-months
Health status	Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.	16-weeks
Health status	Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.	6-months
Health status	Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.	12-months
Aerobic capacity	Six minute walk test	16-weeks
Aerobic capacity	Six minute walk test	6-months
Aerobic capacity	Six minute walk test	12-months
Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	16-weeks
Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	6-months
Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	12-months
Cardiovascular outcomes - Heart rate	Resting heart rate	16-weeks
Cardiovascular outcomes - Heart rate	Resting heart rate	6-months
Cardiovascular outcomes - Heart rate	Resting heart rate	12-months
Health care utilization	Measured using the 'Health care utilization scale'. Minimum score: 0, no maximum score. Higher values represent higher health care utilization and higher costs.	16-weeks
Health care utilization	Measured using the 'Health care utilization scale'. Minimum score: 0, no maximum score. Higher values represent higher health care utilization and higher costs.	6-months
Health care utilization	Measured using the 'Health care utilization scale'. Minimum score: 0, no maximum score. Higher values represent higher health care utilization and higher costs.	12-months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; Canadian Cancer Society (CCS); Niagara Health System

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IMPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No