Enhancing the Patient Journey to Clinical Trial Enrolment With Navigation to Optimize Accrual

NCT06905002 | Recruiting

• 1 other identifier: 22-439
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Less than 5% of patient enter clinical trials, despite the fact that many patients facing cancer are recommended to seek out clinical trials. One challenge of finding a clinical trial, is the lack of clinical trials at the patient's home cancer centre. The Clinical Trials Navigator (CTN) program was established to help patients, their families and heath care providers navigate the clinical trials systems across Canada in order to identify meaningful clinical trials for patients and help them enter those trials. The CTN program was piloted in Windsor, Ontario and increased clinical trials accrual for this population by 8%. This study plans to roll out to twenty centres across Canada, mimicing the process. This implementation of the CTN program will be tested by adding centres in a sequential fashion until all centres are added over the 12 month period. The objectives are improved patient enrollment which will be measured by embedded CTNs in each cancer centre, and reporting to the central site. Pre- and post-implementation structured interviews with administrators, physicians, patients and allied health care professionals will be used to assess uptake of the CTN program in each centre and reveal potential barriers to successful implementation of a nation-wide CTN program. The ability of the current CTN program to upscale to twenty centres will be measured by turn-around times of patient reports and through the structured interviews.

Conditions

Cancer

Keywords

Clinical trials navigator

Outcome Measures

Primary Outcomes (2)

• At least a 10% increase in the number of patients from Thunder Bay and Winnipeg referred to clinical trials outside of the patient's home cancer treatment site.

  Following the intervention, increased awareness of the program will increase the numbers of cancer patients referred to clinical trials at sites outside of the treating site.

  12 months

• At least a 5% increase in the number of patients from Thunder Bay and Winnipeg enrolled onto clinical trials outside of the patient's home cancer treatment site.

  Following the intervention, increased awareness of the program will increase the numbers of cancer patients enrolled onto clinical trials at sites outside of the treating site.

  12 months

Secondary Outcomes (1)

• Health Care Professional Interviews

  12 months

Study Arms (2)

Cohort 1: Patients: Pre and post intervention

ACTIVE COMPARATOR

In the two time periods: pre - intervention and post-intervention, patient charts will be reviewed to assess referral to and accrual onto clinical trials outside of their home cancer treatment centre.

Behavioral: Educational program

Cohort 3: Physicians and Health Care Professionals

ACTIVE COMPARATOR

This group will be followed throughout the pre and post intervention period with regular surveys requesting input on number of patients referred to and accrued onto clinical trials outside of the patient's home cancer treatment centre.

Behavioral: Educational program

Interventions

Educational program BEHAVIORAL

Unique educational program that educates health care professionals on the unique advantages of the Clinical Trials Navigator program. This program is reserved for those centres entering the study. An interactive component of the study is central.

Cohort 1: Patients: Pre and post intervention; Cohort 3: Physicians and Health Care Professionals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Limited to Thunder Bay and Winnipeg health care professionals and patients;

You may not qualify if:

• People outside of these two expansion sites

Sponsors & Collaborators

• Windsor Regional Hospital: lead

Study Sites (1)

Windsor Regional Hospital

Windsor, Ontario, N8W 1L9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Caroline M Hamm, MD

  Western Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Hamm, MD

CONTACT

15192535253; caroline.hamm@wrh.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient information will be masked by replacing clinical sensitive information with unique identifiers. Health care professional identifying information will be replaced with unique identifiers.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Stepped-Wedge Cluster- Randomized Control Trial

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1)