Physiotherapist Navigator Pilot Trial

NCT ID: NCT07045740

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-21
• Study Completion Date: 2026-05-01

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PT Navigator

Group Type: EXPERIMENTAL

PT Navigator

Intervention Type: 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.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PT Navigator

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenna Smith-Turchyn, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Holly Edward, PT, PhD Candidate

Role: CONTACT

edwarh2@mcmaster.ca

905-525-9140

Facility Contacts

Som D Mukherjee, MD, MSc

Role: primary

mukherjee@hhsc.ca

905-387-9495

Jenna Smith-Turchyn, PT, PhD

Role: backup

smithjf@mcmaster.ca

Other Identifiers

PT Navigator

Identifier Type: -

Identifier Source: org_study_id