Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials

Abstract

Purpose Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute–designated comprehensive cancer center. Methods Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Results Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Conclusion Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non–patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.

The efficacy and cost‐effectiveness of patient navigation programs across the cancer continuum: A systematic review

“…Two studies assessed the efficacy of PN for clinical trial enrollment . Patients in the PN group had higher adherence rates for scheduled study visits and higher completion rates.…”

“…As cancer survival rates continue to improve, increased effort in the survivorship domain will be essential for increasing the efficiency of cancer care and treatment and improving quality of life among survivors. During the 7 years since the last PN review, an additional 2 publications considered PN in clinical trial enrollment . The findings of these studies were promising, with PN resulting in higher rates of adherence to study visits and higher completion rates.…”

Clinical Cancer Advances 2017: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology

“…The IMPaCT (Increasing Minority Participation in Clinical Trials) project was the first to use patient navigation to address such barriers (this study was funded by a grant from the NIH). 79 Between 2007 and 2014, more than 400 African American patients with cancer were referred to IMPaCT. Patient navigators matching the demographic characteristics of patients provided guidance to project participants.…”

Racial Differences in Cancer Susceptibility and Survival: More Than the Color of the Skin?

“…In clinical trials, independent of the discipline, there is often a selection bias in terms of age (younger), gender (males) and race with more European/Caucasian patients being included [91], resulting in underrepresentation of African American, Hispanic and Asian patients (<10% of clinical trial participants are minorities) [92]. In addition to improving access to novel therapies, participation of racial groups in clinical trials is critical to reach robust conclusions about the risks and benefits of drugs and specific interventions in these populations.…”

“…The patient navigation model, where a lay individual is trained to provide support and education for patients enrolled in trials, has been successfully applied to improve health care access and increase participation and retention in clinical trials [92]. …”