Introduction: Clinical trials are essential to the advancement of clinical therapies that improve the outcomes of people with cancer. However, enrollment in clinical trials remains a challenge. The Clinical Trial Navigator [CTN] Program was designed to address the current gap in the cancer care journey by assisting with the clinical trials search process. Methods: Between March 2019 and July 2024, applicants of the CTN program included people with cancer, their family members, and/or their care team. Applicants entered the CTN program through a REDCap^® survey that collected the patient’s medical history. A final curated list of potential clinical trials was provided to the applicant. Metrics of success included clinical trial referral and enrollment, and we examined the factors that impacted these outcomes. Results: A total of 445 people with cancer applied to the CTN program during the study. Of the 262 patients with referral and enrollment information, a trial referral occurred in 27.5% [n = 72]. Of the 72 patients who were referred to a clinical trial, 13 [18.1%] were enrolled, 9 [12.5%] are pending enrollment, and 50 [69.4%] were not enrolled. We identified a potential trial for 88% of applicants, with a median of one potential trial per patient. Physicians were highly involved as applicants. Interpretation: The CTN program is successful in searching for clinical trials for people with cancer. Ongoing implementation into other Canadian sites, assessments of patient-reported outcomes, website and social media campaigns, and research into the factors that impact referral and enrollment are underway.

Introduction Interventions are needed to increase participation in clinical trials through optimised trial design and enrolment workflows. Patient navigation is a promising intervention for increasing participation in clinical trials by optimising enrolment workflows. Patient navigation is defined as a personalised intervention aimed at overcoming barriers and ensuring timely access to healthcare services, diagnosis, treatment and care. This scoping review aims to fill a gap in current literature by summarising what is known about patient navigation, aiming to increase clinical trial participation. Methods and analysis A search was conducted for peer‐reviewed literature published in English from inception through 21 December 2023, and the search was updated on 5 March 2025. Sources of literature included Cochrane CENTRAL (Ovid), MEDLINE (Ovid), EMBASE (Ovid), Cumulative Index of Nursing and Allied Health (CINAHL; on EBSCOhost; EBSCO Industries, Inc), Epistemonikos and PROSPERO databases. Searches were also conducted through the Turning Research into Practice and International Clinical Trials Registry Platform (WHO) databases, Google Scholar and the Agency for Health Research and Quality platform to ensure the retrieval of all relevant articles. Reference lists of eligible studies were also examined. The Google Scholar search was limited to the first 10 pages of results. The search strategy focused on the following key concepts: navigation (eg, navigator, care coordination, case management) and clinical trials. Searches were reviewed using the PRESS Peer Review of Electronic Search Strategies 2015. This review was guided based on the JBI methodology for scoping reviews using a five-step review process: identify the research questions; search and identify relevant studies; select studies based on a priori criterion; chart the data; and collate, summarise and report the results according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. Ethics and dissemination This scoping review identifies and analyses existing research; therefore, ethics approval is not required. Findings will be disseminated through conference presentations and a publication in a scientific journal.

Patient navigation is a promising intervention to address barriers and improve access to cancer clinical trials. Although navigation has been widely studied across the cancer continuum, its role in facilitating clinical trial participation has not been systematically evaluated. This scoping review aims to identify, characterize, and synthesize evidence on patient navigation interventions designed to increase access to cancer clinical trials. Nine databases were searched for English peer-reviewed articles from inception through 5 March 2025. Two independent researchers screened titles, abstracts, and full texts and extracted data using standardized forms. The results were interpreted using descriptive statistics and collated using predetermined conceptual frameworks. Of 10,238 citations identified, 23 studies met inclusion criteria. All were conducted in North America, and five (21.7%) were randomized controlled trials. Thirteen studies (56.5%) evaluated enrollment outcomes, with mixed results. One randomized trial and two observational studies found no significant effect, while three observational studies and seven single-arm reports suggested improved enrollment. Navigation interventions most commonly included education/information provision (100%), care coordination (60.9%), and empowerment (47.8%). Navigators were primarily lay navigators (73.9%), often selected for community or lived experience; training varied widely, and only two programs reported certification. Fifteen studies (65.2%) targeted equity-deserving groups, most frequently racial and ethnic minorities, with reports of increased representation in trial enrollment. Patient navigation shows promise in improving access to cancer clinical trials, particularly for equity-deserving populations, but current evidence is limited, heterogeneous, and largely observational. Standardized definitions, rigorous trial designs, and reporting of navigator training and outcomes are needed to clarify effectiveness.