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Related Experiment Video

Updated: Sep 13, 2025

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Implementation of a Patient Navigation Program to Support Representative Participation in Cancer Clinical Trials.

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A patient navigation program successfully enrolled diverse oncology patients in clinical trials. This initiative improved access to financial navigation and fostered future trial interest, addressing key challenges in cancer research enrollment.

Keywords:
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Area of Science:

  • Oncology
  • Clinical Research
  • Health Equity

Background:

  • Clinical trial enrollment faces challenges with diversity, impacting generalizability of findings.
  • Patient representation in oncology trials is often insufficient, particularly for minority populations.
  • Navigation services can potentially improve patient awareness, access, and retention in clinical trials.

Purpose of the Study:

  • To implement and evaluate a patient navigation program aimed at enhancing diverse enrollment and retention in cancer clinical trials.
  • To assess the feasibility, acceptability, and reach of a patient navigation program in diverse healthcare settings.
  • To identify proximal outcomes such as financial navigation receipt and expressed trial interest.

Main Methods:

  • A patient navigation program was implemented from July 2023 to July 2024 in a university and a safety-net healthcare system.
  • The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework guided the evaluation.
  • Data collection included programmatic records, patient/staff surveys, and qualitative patient interviews.

Main Results:

  • The program served 429 oncology patients, with higher representation of Hispanic/Latino, female, and minority race individuals compared to the general patient population.
  • Of contacted patients not enrolled in a trial, 47% expressed future interest in clinical trial participation.
  • 92% of patients already enrolled in a trial received financial navigation support for retention.

Conclusions:

  • Patient navigation is a feasible and acceptable method for reaching underrepresented populations in cancer clinical trials.
  • The program demonstrated success in engaging priority populations and providing support services.
  • Further investigation is needed to confirm the impact of navigation on clinical trial enrollment and retention rates.