CancerNCT07045740
Physiotherapist Navigator Pilot Trial
A study testing PT Navigator in people with Cancer, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PT Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have a self-reported physical or cognitive impairment that would prevent them from carrying out a physical assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Som D Mukherjee, MD, MSc, 905-387-9495, mukherjee@hhsc.ca
Jenna Smith-Turchyn, PT, PhD, smithjf@mcmaster.ca
About this study
Official 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
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:
Read more
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.
Read the 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
- Being tested
- PT Navigator
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT NavigatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PT Navigator | Experimental | Not described Receives: Other: PT Navigator |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate
Adherence will be measured dichotomously through attendance (i.e., yes/no) at each session by the PT Navigator
Measured: 12-18 weeks
Secondary outcomes (18)
Retention Rate
Retention will be measured by the number of individuals who complete both a baseline and follow up assessment
Measured: 12-18 weeks
Recruitment Rate
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
Measured: 12-18 weeks
Participant Satisfaction
7-point Likert scale; 1-7 - higher scores indicate greater satisfaction
Measured: 12-18 weeks
Participant Satisfaction
7-point Likert scale; 1-7 - higher scores indicate greater satisfaction
Measured: 20-26 weeks
Overall Impairment Score
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
Measured: 12-18 weeks weeks
Overall Impairment Score
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
Measured: 20-26 weeks
Self-Reported Exercise Volume
Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
Measured: 12-18 weeks
Self-Reported Exercise Volume
Godin Leisure Time Exercise Questionnaire (higher scores represent higher volume of exercise)
Measured: 20-26 weeks
Health-Related Quality of Life
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
Measured: 12-18 weeks
Health-Related Quality of Life
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
Measured: 20-26 weeks
Health-Related Quality of Life
Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL; Total scores range from 0-108
Measured: 12-18 weeks
Health-Related Quality of Life
Functional Assessment of Cancer Therapy - General (FACT-G); higher scores represent better QoL; Total scores range from 0-108
Measured: 20-26 weeks
Health Care Utilization
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.
Measured: 12-18 weeks
Health Care Utilization
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.
Measured: 20-26 weeks
Physical Functioning
30 second Sit to Stand
Measured: 12-18 weeks
Physical Functioning
30 second Sit to Stand
Measured: 20-26 weeks weeks
Exercise Capacity
6 minute Walk Test
Measured: 12-18 weeks
Exercise Capacity
6 minute Walk Test
Measured: 20-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start21 Nov 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna Smith-Turchyn, PT, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045740
- Sponsor's protocol ID
- PT Navigator
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edward H, Macedo L, Wojkowski S, Mukherjee SD, Smith-Turchyn J. Evaluation of a novel role proposal for the use of a physiotherapist navigator in an acute cancer care setting in Ontario: Protocol for a pilot randomized controlled trial. PLoS One. 2026 Jun 23;21(6):e0351761. doi: 10.1371/journal.pone.0351761. eCollection 2026.
PubMed 42335134
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07045740
- Acronym / sponsor ID
- PT Navigator
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT Navigator | Experimental | Other: PT Navigator |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- have a self-reported physical or cognitive impairment that would prevent them from carrying out a physical assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT NavigatorParticipants 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. | Other | PT Navigator |
Primary outcome
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
18 secondary outcomes
Retention Rate
Time frame: 12-18 weeks
Recruitment Rate
Time frame: 12-18 weeks
Participant Satisfaction
Time frame: 12-18 weeks
Participant Satisfaction
Time frame: 20-26 weeks
Overall Impairment Score
Time frame: 12-18 weeks weeks
Overall Impairment Score
Time frame: 20-26 weeks
Self-Reported Exercise Volume
Time frame: 12-18 weeks
Self-Reported Exercise Volume
Time frame: 20-26 weeks
Health-Related Quality of Life
Time frame: 12-18 weeks
Health-Related Quality of Life
Time frame: 20-26 weeks
Health-Related Quality of Life
Time frame: 12-18 weeks
Health-Related Quality of Life
Time frame: 20-26 weeks
Health Care Utilization
Time frame: 12-18 weeks
Health Care Utilization
Time frame: 20-26 weeks
Physical Functioning
Time frame: 12-18 weeks
Physical Functioning
Time frame: 20-26 weeks weeks
Exercise Capacity
Time frame: 12-18 weeks
Exercise Capacity
Time frame: 20-26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 42335134Edward H, Macedo L, Wojkowski S, Mukherjee SD, Smith-Turchyn J. Evaluation of a novel role proposal for the use of a physiotherapist navigator in an acute cancer care setting in Ontario: Protocol for a pilot randomized controlled trial. PLoS One. 2026 Jun 23;21(6):e0351761. doi: 10.1371/journal.pone.0351761. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenna Smith-Turchyn, PT, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT Navigator in people with Cancer, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Edward, PT, PhD Candidate (905-525-9140, edwarh2@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Rate (time frame: 12-18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.