Challenges and Successes in Recruiting African Americans with Early Stage, Non-Small Cell Lung Cancer to an NIMHD-Funded, NCORP-based Patient Navigation Trial

Authors:

Marvella Ford (Presenter)
Medical University of South Carolina

Debbie Bryant, Medical University of South Carolina
Kathleen Cartmell, Medical University of South Carolina
Katherine Sterba, Medical University of South Carolina
Dana Burshell, Medical University of South Carolina
Elizabeth Hill, Medical University of South Carolina
Allan De Toma, Clemson University
Kendrea Knight, Medical University of South Carolina
Kathyrn Weaver, Wake Forest
Elizabeth Calhoun, University of Arizona
Nestor Esnaola, Fox Chase Cancer Center

Public Health Statement: Enrollment of early-stage lung cancer patients to randomized trials has historically been challenging. The STARS Trial enrolled 36 of 1,030 intended patients from 28 sites, while the ROSEL Trial recruited 22 of 960 intended patients from 10 sites. Unfortunately, evidence shows African Americans (AAs) with early-stage NSCLC are significantly less likely than their non-Hispanic white (NHW) counterparts to receive surgery, and may also be less likely to participate in lung cancer trials.

Purpose: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation (PN) trial that is evaluating the effectiveness of the PN intervention in improving rates of lung-directed, curative-intent therapy (surgery and stereotactic body radiation therapy (SBRT)) in AAs with Stage I-II NSCLC.

Methods/Approach: The protocol-driven, barrier-focused PN intervention is being tested in a two-arm cluster-randomized trial (PN intervention vs. usual care). The trial includes 23 study sites in 13 US states, with an accrual goal of 200 participants. Trial recruitment enhancement activities include contacting physicians from multiple disciplines (e.g., primary care, pulmonology, radiology) to increase referral of AA patients to the trial, and raising community awareness of the trial.

Results: To date, 111 AAs have been recruited, with a 90% consent rate. The majority of potential participants were ineligible due to receipt of surgery or SBRT prior to enrollment (27%), or having a later-stage lung cancer diagnosis (25%).

Conclusions/Implications: The recruitment strategies have high potential applicability in future clinical trials that seek to improve the cancer health outcomes of AAs.