Physiotherapist Navigator Pilot Trial

NCT07045740 | Recruiting

• 1 other identifier: PT Navigator
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Adherence Rate

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

  12-18 weeks

Secondary Outcomes (18)

• Retention Rate

  12-18 weeks

• Recruitment Rate

  12-18 weeks

• Participant Satisfaction

  12-18 weeks

• Participant Satisfaction

  20-26 weeks

• Overall Impairment Score

  12-18 weeks weeks

Study Arms (2)

PT Navigator

EXPERIMENTAL

Other: PT Navigator

Usual Care

NO INTERVENTION

Interventions

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.

PT Navigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jenna Smith-Turchyn, PT, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Edward, PT, PhD Candidate

CONTACT

905-525-9140; edwarh2@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: November 21, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)