Patient barriers to cancer clinical trial participation and navigator activities to assist.

Clinical research is vital to the discovery of new cancer treatments that can enhance health and prolong life for cancer patients, but breakthroughs in cancer treatment are limited by challenges recruiting patients into cancer clinical trials (CT). Only 3-5% of cancer patients in the United States participate in a cancer CT and there are disparities in CT participation by age, race and gender. Strategies such as patient navigation, which is designed to provide patients with education and practical support, may help to overcome challenges of CT recruitment. The current study evaluated an intervention in which lay navigators were utilized to provide patient education and practical support for helping patients overcome barriers to CT participation and related clinical care. A patient barrier checklist was utilized to record patient barriers to CT participation and care, actions taken by navigators to assist patients with these barriers, and whether or not these barriers could be overcome. Forty patients received patient navigation services. The most common barriers faced by navigated patients were fear (n=9), issues communicating with medical personnel (n=9), insurance issues (n=8), transportation difficulties (n=6) and perceptions about providers and treatment (n=4). The most common activities undertaken by navigators were making referrals and contacts on behalf of patients (e.g., support services, family, clinicians; n=25). Navigators also made arrangement for transportation, financial, medication and equipment services for patients (n=11) and proactively navigated patients (n=8). Barriers that were not overcome for two or more patients included insurance issues, lack of temporary housing resources for patients in treatment and assistance with household bills. The wide array of patient barriers to CT participation and navigator assistance documented in this study supports the CT navigator role in facilitating quality care.

Patient participation in cancer clinical trials: A pilot test of lay navigation.

BACKGROUND: Clinical 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. METHODS: A 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-minute 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%-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. 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. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.