The IMPACT Implementation-Effectiveness Trial

Cancer Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323707
• Other study ID #: IMPACT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 15, 2024
• Est. completion date: March 15, 2027

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Jenna Smith-Turchyn, PT, PhD
• Phone: 905-525-9140
• Email: smithjf[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 129
• Est. completion date: March 15, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Cancer Society (CCS), Hamilton Health Sciences Corporation, Niagara Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level	Godin Leisure Time Exercise Questionnaire	16-weeks
Secondary	Physical activity level	Godin Leisure Time Exercise Questionnaire	6-months
Secondary	Physical activity level	Godin Leisure Time Exercise Questionnaire	12-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Aerobic capacity	Six minute walk test	16-weeks
Secondary	Aerobic capacity	Six minute walk test	6-months
Secondary	Aerobic capacity	Six minute walk test	12-months
Secondary	Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	16-weeks
Secondary	Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	6-months
Secondary	Cardiovascular outcomes - Blood pressure	Resting Blood Pressure	12-months
Secondary	Cardiovascular outcomes - Heart rate	Resting heart rate	16-weeks
Secondary	Cardiovascular outcomes - Heart rate	Resting heart rate	6-months
Secondary	Cardiovascular outcomes - Heart rate	Resting heart rate	12-months
Secondary	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
Secondary	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
Secondary	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