Enhancing the Patient Journey to Clinical Trial Enrolment With Navigation to Optimize Accrual: A Pilot Study for a Prospective, Pragmatic Multi-centre, Stepped Wedge, Cluster Randomized Controlled Trial

PROTOCOL SYNOPSIS In Canada, less than 5% of people living with cancer enroll in clinical trials. The rate of enrollment in trials is even lower among rural populations. The most common barrier to trial enrollment, impacting 30 - 60% of individuals living with cancer, is lack of availability of clinical trials (1-3).

To address this barrier, the Clinical Trials Navigator (CTN) program was developed with support from the Canadian Cancer Clinical Trials Network (3CTN)(4, 5) and hosted by the Windsor Regional Hospital (WRH) in 2019. The objective of this CTN Pilot Trial is to determine the the effectiveness of the CTN program in increasing trial referral rates in twenty new centers across Canada. If we demonstrate that the CTN program can increase the rate of referral to trials across diverse sites in Canada, the CTN program will be a viable solution to overcoming one of the most significant barriers to trial enrollment, thereby advancing treatments and improving outcomes for people living with cancer.

1. THE NEED FOR A TRIAL 1.1.1 What is the problem to be addressed? Clinical trials remain the gold standard to advancing treatments and improving outcomes for people living with cancer. Less than 5% of people living with cancer enroll in trials. The rate of trial enrollment is even lower in rural populations and community hospitals, which account for 65% of hospitals in Canada.(1-3). The most common barrier to trial enrollment, impacting 30 - 60% of individuals living with cancer, is lack of availability of clinical trials, especially among those treated in smaller centres(1-3). Trial availability in Canada ranges from one to 350 trials per center, with larger urban academic centers having more available trials. [Appendix A Accrual by site]. This means many people living with cancer in Canada will be referred to trials that are not available in the center where they receive the majority of their cancer treatment (i.e., a patient's treating cancer center). Stakeholders agree the process of identifying available trials outside of a patient's treating cancer center is the most important barrier currently preventing trial accrual in Canada. (6, 7). 1.1.2 The Clinical Trials Navigator (CTN) Program Structure In 2019, the CTN program was designed in collaboration with key stakeholders, including with people with lived experience (PWLE), to resolve the gap in navigating enrollment into available trials. The CTN program currently incorporates several key components to enhance the trial enrollment process: (i) Publicly accessible referral process through the 3CTN website and posters in the WRH [Appendix B url] [Appendix C poster] (ii) Expert navigators trained in conducting thorough searches to identify available trials (iii) Continuous quality improvement through tracking key metrics that inform ongoing optimization of the CTN program (iv) Knowledge dissemination including sharing best practices and valuable insights with the broader community.

1.1.3 The Effectiveness of the CTN Program The process from initial referral to the CTN program to trial enrollment is outlined in Appendix D.

Since inception in 2019, over 600 patients from across Canada have been referred to the CTN program, with 26% being referred to a clinical trial and 8% enrolling in an interventional clinical trial (8). An ongoing iterative process allowed the following improvements: (i) a new EDI survey which allowed users to self-identify as evidenced by one aboriginal and one trans-gender person in our database, (ii) Master Lists for all major cancer types have been developed to overcome challenges of search engines (7). We have demonstrated these master lists increase meaningful trial identification over existing resources [Appendix E, Master List]