Enhancing the patient journey to clinical trial enrollment with navigation to optimize accrual: A pilot study for a pragmatic multicentre, stepped wedge, cluster randomized controlled trial (The CTN Pilot Trial).

11093 Background: Clinical trials are essential to the advancement of clinical therapies, yet accrual rates remain disappointing. Multiple challenges lead to less than 5% of cancer patients enrolled onto clinical trials. The Clinical Trials Navigator (CTN) program was established to assist patients and health care professionals identify appropriate clinical trials for patients. Methods: Between March 2019 to January 2024, a novel navigator-assisted clinical trials search program was offered to Canadian patients. Three non-medical navigators were trained to receive referrals, review medical information, and search five different clinical trial search engines. Eligibility criteria was scrutinized. A second review of the clinical trial list was conducted by two physicians. The final curated list of clinical trials was provided to patients and their oncologist. Results: A total of 373 patients were referred to the CTN program during the study period. A unique clinical trial search was performed for each patient yielding a median of only one potentially eligible trial per patient. Clinical trial enrolment occurred in 3.2% of patients in our database which translates to a 19% rate of successful enrolment of those referred to a trial by the CTN. Most patients (78%) were referred to clinical trial sites that conducted more than 100 clinical trials at any time. Compared to the Canadian cancer statistics, lung, lymphoma, pancreatic and brain cancers were overrepresented in referrals to the CTN program while prostate cancer was underrepresented. Type of cancer played a significant role in the likelihood of a successful referral (p < 0.01). Lung cancer was the most frequently reported cancer that resulted in referrals and breast cancer showed a lower frequency of referrals. The cancer type, stage and number of lines of prior therapy were not significantly associated with the patient enrollment onto a clinical trial. An increase in survival of referred patients from last analysis from 3.0 months to 5.3 months. Conclusions: The CTN program is a successful tool to identify clinical trials for cancer patients and can improve clinical trial accrual, as almost one fifth of patients (19%) who were referred to a clinical trial were enrolled. Ongoing iterative changes to the program to improve these metrics are underway and efforts to improve implementation of the CTN program across Canada are ongoing.