Physiotherapist Navigator Pilot Trial

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT07045740
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

METHODS 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, 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:

This is a two-arm single-blinded (outcome assessment) pilot randomized control trial. Our methods adhere to the CONSORT guidelines extended to pilot and feasibility trials. The Hamilton Integrated Research Ethics Board will approve this study. Participants will be randomized (1:1) to the intervention (PT Navigator) or control (usual care) group prior to baseline assessment. Allocation of participant randomization will be concealed using RedCap (https://project-redcap.org/) by a graduate student external to the research team.

Intervention Group (PT Navigator):

Process: Participants allocated to this group will be introduced by their medical oncologist to the PT Navigator within the first month of starting treatment (e.g., chemotherapy, radiation, immunotherapy). The PT Navigator will perform an initial assessment (approximately 1 hour in length including both subjective and objective components) and administer evidence-based self-reported outcome measures validated for use in oncological populations. Following the assessment, the PT Navigator will use their clinical reasoning and outcome measure scoring interpretations to guide decision making on next steps. The PT Navigator will follow up with the patient every two to three weeks at the Juravinski Cancer Centre (JCC) in Hamilton, Ontario, for a total of six sessions. To increase accessibility, sessions with the PT Navigator will be scheduled for when the patient is already coming to the JCC for a scheduled treatment and/or appointment with their oncologist. However, patients will be given the option to schedule check-in sessions on different days if needed or desired. Check-in appointments (approximately 30-minutes long) will include a verbal screen for complications, repeat assessments as indicated, and consider triaging decisions based on their findings and clinical reasoning early during treatment.

Roles/Decisions: The PT Navigator will administer outcome measures and continuously screen for complications or side effects of treatment (i.e., fatigue, chemotherapy-induced peripheral neuropathy). If complications or side-effects are identified by the PT Navigator, they will make recommendations and/or referrals to other health practitioners as appropriate (e.g., dietician, social work). Further, if indicated, the PT Navigator will provide exercise and physical activity recommendations to prevent impairment and maintain function. The PT Navigator will also assist participants in setting goals and developing action plans focused on functional activity or reduction in symptoms during each visit. If a concern is brought up by the participant during the interaction with the PT Navigator that requires the care team's attention (i.e., family situations, financial concerns), the PT Navigator will share it with those involved in their care and document the concerns in the patient's chart. Importantly, the PT Navigator will serve as an advocate to ensure the patient feels supported and aware of all resources available to them. The participants allocated to the intervention group will also be given the PT Navigator's contact information and will be encouraged to communicate with them if they ever have any questions or concerns throughout the intervention period.

Control Group (Usual Care):

Participants in this group will have no interaction with the PT Navigator. They will continue with usual care regarding rehabilitation from their medical oncologist and oncology care team. This care ranges from no discussion of rehabilitation to general advice to stay physically active.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-08-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence Rate	12-18 weeks	Adherence will be measured dichotomously through attendance (i.e., yes/no) at each session by the PT Navigator

Secondary Outcome Measures

Name	Time	Method
Retention Rate	12-18 weeks	Retention will be measured by the number of individuals who complete both a baseline and follow up assessment
Overall Impairment Score	20-26 weeks	Edmonton Symptom Assessment System (ESAS); higher scores represent higher perceived symptom burden
Health-Related Quality of Life	20-26 weeks	Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL
Self-Reported Exercise Volume	20-26 weeks	Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
Health Care Utilization	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.
Physical Functioning	20-26 weeks weeks	30 second Sit to Stand
Exercise Capacity	20-26 weeks	6 minute Walk Test
Recruitment Rate	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
Participant Satisfaction	12-18 weeks	7-point Likert scale

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada