Connecting Patients with Clinical Trials Using Patient Navigation: A Scoping Review.

Area of Science:

• Oncology
• Health Services Research
• Clinical Trials

Background:

• Patient navigation is a key strategy to overcome barriers in cancer care.
• Its specific impact on cancer clinical trial participation requires systematic evaluation.
• Existing evidence on navigation for clinical trials is limited and diverse.

Purpose of the Study:

• To systematically review and synthesize evidence on patient navigation interventions aimed at increasing access to cancer clinical trials.
• To characterize the types of navigation interventions, navigator roles, and target populations.
• To identify gaps in the current research landscape.

Main Methods:

• A comprehensive scoping review of nine databases was conducted for English peer-reviewed articles.
• Two independent researchers screened over 10,000 citations and extracted data.
• Results were analyzed using descriptive statistics and conceptual frameworks.

Main Results:

• Twenty-three studies met inclusion criteria, all from North America; 21.7% were randomized controlled trials.
• Enrollment outcomes were mixed; some studies showed improvement, others no significant effect.
• Interventions commonly included education, care coordination, and empowerment, often utilizing lay navigators.
• Fifteen studies targeted equity-deserving groups, reporting increased trial enrollment representation.

Conclusions:

• Patient navigation demonstrates potential for enhancing cancer clinical trial access, particularly for underserved populations.
• The current evidence base is limited by heterogeneity, reliance on observational data, and lack of standardized reporting.
• Further research with standardized definitions, robust trial designs, and clear reporting on navigator training and outcomes is essential.