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NCT Number: NCT06323707

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Joseph Brant Hospital, Burlington, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Exercise

Behavioral

Eight sessions of moderate intensity aerobic exercise using recumbent bike within the cancer institution.

Self-management e-module

Behavioral

Eight 15 minute self-management e-modules related to exercise and physical activity for cancer survivors.

Primary outcomes

  1. Physical activity level

    Time frame: 16-weeks

    Godin Leisure Time Exercise Questionnaire

  2. Physical activity level

    Time frame: 12-months

    Godin Leisure Time Exercise Questionnaire

  3. Physical activity level

    Time frame: 6-months

    Godin Leisure Time Exercise Questionnaire

Secondary outcomes

  1. Quality of life

    Time frame: 16-weeks

    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.

  2. Quality of life

    Time frame: 6-months

    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.

  3. Quality of life

    Time frame: 12-months

    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.

  4. Level of exercise knowledge

    Time frame: 16-weeks

    Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.

  5. Level of exercise knowledge

    Time frame: 6-months

    Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.

  6. Level of exercise knowledge

    Time frame: 12-months

    Measured using the 'Theory of Planned Behaviour Questionnaire'. Total scores range from 8-56 with higher scores representing higher levels of exercise knowledge.

  7. Health status

    Time frame: 16-weeks

    Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.

  8. Health status

    Time frame: 6-months

    Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.

  9. Health status

    Time frame: 12-months

    Measured using the Eq-5d-3L VAS. Measured on a scale of 0-100 with higher scores representing higher levels perceived health status.

  10. Aerobic capacity

    Time frame: 16-weeks

    Six minute walk test

  11. Aerobic capacity

    Time frame: 6-months

    Six minute walk test

  12. Aerobic capacity

    Time frame: 12-months

    Six minute walk test

  13. Cardiovascular outcomes - Blood pressure

    Time frame: 16-weeks

    Resting Blood Pressure

  14. Cardiovascular outcomes - Blood pressure

    Time frame: 6-months

    Resting Blood Pressure

  15. Cardiovascular outcomes - Blood pressure

    Time frame: 12-months

    Resting Blood Pressure

  16. Cardiovascular outcomes - Heart rate

    Time frame: 16-weeks

    Resting heart rate

  17. Cardiovascular outcomes - Heart rate

    Time frame: 6-months

    Resting heart rate

  18. Cardiovascular outcomes - Heart rate

    Time frame: 12-months

    Resting heart rate

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Smith-Turchyn, PT, PhD

CONTACT

[email protected]

905-525-9140

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Hamilton Health Sciences Corporation
  • Niagara Health System

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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