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

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.

Study Timeline

• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Status Verified: 2025-07
• Study First Posted: 2025-07-01
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• 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
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	20-26 weeks	7-point Likert scale; 1-7 - higher scores indicate greater satisfaction
Overall Impairment Score	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
Self-Reported Exercise Volume	20-26 weeks	Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
Health-Related Quality of Life	20-26 weeks	Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL; Total scores range from 0-108
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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada