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NCT Number: NCT07045740

Physiotherapist Navigator Pilot Trial

Background: More Canadians are living with and beyond cancer in Canada. However, most survivors live with harsh side effects due to cancer and its treatments. While international guidelines recommend involving physiotherapists (PTs) in cancer care, many countries do not provide access to these services as a standard part of treatment. Healthcare navigators help patients overcome barriers and streamline care which has shown to improve clinical processes while reducing clinical and patient costs. Through ongoing and routine assessment, a PT Navigator could specifically address issues like fatigue and strength loss, refer patients to other needed services, and help set goals to improve quality of life. Currently, there are no PT Navigator roles in acute cancer care settings in Canada. The purpose of this study is to examine the feasibility and preliminary effectiveness of a PT Navigator role for individuals living with cancer receiving cancer treatment.

Methods:

Participants will include adults recently diagnosed with cancer who are/will be receiving cancer treatment (e.g., chemotherapy, radiation, immunotherapy), are English-speaking and community dwelling. Participants in the intervention group will be followed by the PT Navigator for 12-18 weeks who will screen for early side effects of cancer and its treatment and respond or refer accordingly. Participants in the control group will continue with usual care.

Outcomes: Participants will be assessed at 3 time points. The primary outcome is adherence. Secondary outcomes include other feasibility measures such as retention, recruitment, satisfaction, and preliminary effectiveness will be assessed using overall impairment score, self-reported exercise volume, quality of life, health care utilization, exercise capacity and physical function.

Impact:

If feasible, this will be the first study to facilitate routine PT assessment and early intervention as a component of cancer care in Canada. Findings will inform future methods examining the novel role and can improve the way rehabilitation services are provided to individuals living with or beyond cancer in Canada and internationally.

Recruiting

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Rationale: Cancer affects nearly half of Canadians in their lifetime, and while survival rates are improving, many individuals live with long-term side effects that impact their quality of life. Physical activity and rehabilitation have been shown to improve physical function, reduce mental health symptoms, and enhance overall well-being for those living with and beyond cancer. Despite recommendations from international guidelines for physiotherapists (PTs) to be involved in cancer care, only 30% of Canadian cancer survivors have access to rehabilitation services. Incorporating PT Navigators into care teams early into cancer treatment could work to identify and address barriers, provide individualized symptom management, and connect patients with relevant services. However, no research to date has evaluated the role of PTs as navigators in acute cancer care settings in Canada.

Objective and Research Questions:

The objective of this study is to examine the feasibility and preliminary effectiveness of a PT Navigator role for individuals living with cancer receiving cancer treatment (e.g., chemotherapy, radiation, immunotherapy) in an acute cancer care setting.

Research Question 1 (Primary): Is a PT-Navigator role feasible to implement at a cancer institution in Ontario, Canada? Research Question 2 (Secondary): Do individuals with cancer who are monitored by a PT-Navigator demonstrate trends for improved outcomes in overall impairment score, QOL, physical activity levels, exercise capacity, functional strength, activity limitations, and a reduction in health care utilization costs compared to individuals with cancer who are not monitored by a PT Navigator during treatment?

Study Design: Pilot randomized control trial Participants: Adults aged ≥18 years old, recently diagnosed with any type/stage of cancer who are/will be receiving cancer treatment (e.g., chemotherapy, radiation, immunotherapy), English-speaking, and are community-dwelling Procedure: Participants will be randomized to two groups. Intervention Group (PT Navigator): An assessment and 6 follow up sessions approximately every 2-3 weeks with the PT Navigator.

Control Group (Usual Care): No intervention.

Significance:

Results of this study will aim to maximize the success and feasibility of the role when trialed in a future larger scaled randomized controlled trial. The overall goal of the project is to facilitate routine assessment and early intervention as a standard component of cancer care in Canada.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults aged ≥18 years old; recently diagnosed with any type/stage of cancer who are/will be receiving cancer treatment (e.g., chemotherapy, radiation, immunotherapy); English-speaking; are community-dwelling

Exclusion criteria

  • have a self-reported physical or cognitive impairment that would prevent them from carrying out a physical assessment

Treatment and study plan

PT Navigator

Other

Participants assigned to the intervention group will meet with the PT Navigator withing the first month of starting cancer treatment. Following a one-hour initial assessment, the PT Navigator will follow up every two-three weeks for a total of six sessions. The PT Navigator will administer outcome measures to screen for complications or side effects of treatment. If any complications or side-effects are identified, the PT Navigator will facilitate referrals to other health care practitioners, provide exercise and/or rehabilitation treatment, or provide education and continue monitoring.

Primary outcomes

  1. Adherence Rate

    Time frame: 12-18 weeks

    Adherence will be measured dichotomously through attendance (i.e., yes/no) at each session by the PT Navigator

Secondary outcomes

  1. Retention Rate

    Time frame: 12-18 weeks

    Retention will be measured by the number of individuals who complete both a baseline and follow up assessment

  2. Recruitment Rate

    Time frame: 12-18 weeks

    To assess recruitment rate, electronic records will be kept detailing the source and date of recruitment offer and how many eligible referrals are enrolling into the study

  3. Participant Satisfaction

    Time frame: 12-18 weeks

    7-point Likert scale; 1-7 - higher scores indicate greater satisfaction

  4. Participant Satisfaction

    Time frame: 20-26 weeks

    7-point Likert scale; 1-7 - higher scores indicate greater satisfaction

  5. Overall Impairment Score

    Time frame: 12-18 weeks weeks

    Edmonton Symptom Assessment System (ESAS); higher scores represent higher perceived symptom burden; scores ranging from 0 to 10, where 0 indicates the symptom is absent and 10 indicates the worst possible severity

  6. Overall Impairment Score

    Time frame: 20-26 weeks

    Edmonton Symptom Assessment System (ESAS); higher scores represent higher perceived symptom burden; scores ranging from 0 to 10, where 0 indicates the symptom is absent and 10 indicates the worst possible severity

  7. Self-Reported Exercise Volume

    Time frame: 12-18 weeks

    Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)

  8. Self-Reported Exercise Volume

    Time frame: 20-26 weeks

    Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)

  9. Health-Related Quality of Life

    Time frame: 12-18 weeks

    EORTC QLQ-C30; a high score for a functional scale represents a high level of functioning, a high score for the QoL represents a high QoL, a high score for a symptom scale represents a high level of symptomatology; a scale of 0 to 100

  10. Health-Related Quality of Life

    Time frame: 20-26 weeks

    EORTC QLQ-C30; a high score for a functional scale represents a high level of functioning, a high score for the QoL represents a high QoL, a high score for a symptom scale represents a high level of symptomatology; a scale of 0 to 100

  11. Health-Related Quality of Life

    Time frame: 12-18 weeks

    Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL; Total scores range from 0-108

  12. Health-Related Quality of Life

    Time frame: 20-26 weeks

    Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL; Total scores range from 0-108

  13. Health Care Utilization

    Time frame: 12-18 weeks

    This questionnaire assesses loss of work, procedures received, and all health-related visits (i.e., family doctor, support services). All costs will be calculated according to current (2025) Ontario healthcare standards and presented in CAD.

  14. Health Care Utilization

    Time frame: 20-26 weeks

    This questionnaire assesses loss of work, procedures received, and all health-related visits (i.e., family doctor, support services). All costs will be calculated according to current (2025) Ontario healthcare standards and presented in CAD.

  15. Physical Functioning

    Time frame: 12-18 weeks

    30 second Sit to Stand

  16. Physical Functioning

    Time frame: 20-26 weeks weeks

    30 second Sit to Stand

  17. Exercise Capacity

    Time frame: 12-18 weeks

    6 minute Walk Test

  18. Exercise Capacity

    Time frame: 20-26 weeks

    6 minute Walk Test

Study contacts

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

Holly Edward, PT, PhD Candidate

CONTACT

[email protected]

905-525-9140

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Evaluation of a Novel Role Proposal for the Use of a Physiotherapist Navigator in an Acute Cancer Care Setting in Ontario: a Pilot Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Dec 9, 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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