Abstract

BackgroundClinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators.MethodsA lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-min CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation.ResultsDuring this 12-month pilot project, 85% (95% CI: 72%–93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%–98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation.ConclusionsIn this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Highlights

  • In 2015 cancer is expected to cause more than 589,000 deaths in the US [1]

  • For patients who enrolled in the clinical trials (CT) navigation intervention, we incorporated CT decision support, linkage to community and health-system resources, education about the CT treatment regimen for patients who chose to participate in a CT to empower them in their role to adhere to the therapeutic regimens, and clinical reminders

  • This study examined the feasibility and signs for a potential effect of a lay navigation intervention to provide cancer patients with CT education and support to overcome barriers to CT participation

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Summary

Introduction

In 2015 cancer is expected to cause more than 589,000 deaths in the US [1]. From a societal perspective, clinical trials (CT) are vital to the discovery of efficacious new cancer treatments to reduce the burden of cancer. From the perspective of a cancer patient, CT participation often represents access to clinically advanced treatment options that are delivered with meticulous attention to the treatment protocol. Clinical trials (CT) represent an important treatment option for cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-min CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. Results: During this 12-month pilot project, 85% (95% CI: 72%e93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Conclusions: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment.

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