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Background: 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 with early-stage NSCLC are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. Purpose: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early-stage, probable/proven non-small cell lung cancer (NSCLC). Design: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The 2 study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 20 study sites in 11 US states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community engagement activities at the sites to raise community-level awareness of the trial. Results/Conclusions: To date, 200 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 222 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (24%), not having been told that they had probable/proven NSCLC prior to study contact (22%), or a previous history of lung cancer (10%). The median age of the 200 participants is 65 years (range 40-86 years). Most are unmarried (70%) and have a high school diploma or less (71%). The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant, Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Joanne Kim, Allan De Toma, Kendrea D. Knight, Ta'Myiah Reed, Kathryn Weaver, Elizabeth Calhoun, Nestor F. Esnaola. Challenges and successes in recruiting African Americans with early-stage, non-small cell lung cancer to an NIMHD-funded, NCORP-based patient navigation trial [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A085.

Background: 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 with early-stage non-small cell lung cancer (NSCLC) are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. Purpose: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early-stage, probable/proven NSCLC. Design: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The two study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 24 study sites in 13 U.S. states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community-engagement activities at the sites to raise community-level awareness of the trial. Results/Conclusions: To date, 90 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 200 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (27%), not having been told that they had probable/proven NSCLC prior to study contact (32%), or a previous history of lung cancer (10%). Only 13 potential participants have refused trial participation. The median age of the 90 participants is 66 years (range 51-86 years). Most are unmarried (64%) and have a high school diploma or less (73%). Only 10 of the participants (24%) have no comorbidities. The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant. Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Allan De Toma, Kendrea D. Knight, Kathryn Weaver Elizabeth Calhoun, Nestor F. Esnaola. Interim Recruitment Outcomes in an NCORP-Based Patient Navigation Trial for African Americans with Early Stage Lung Cancer [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A23.

BACKGROUND: 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 with early stage, NSCLC are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. PURPOSE: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early stage, probable/proven non-small cell lung cancer (NSCLC). DESIGN: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The 2 study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 24 study sites in 13 US states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community engagement activities at the sites to raise community-level awareness of the trial. RESULTS/CONCLUSIONS: To date, 64 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 200 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (32%), not having been told that they had probable/proven NSCLC prior to study contact (13%) or a previous history of lung cancer (13%). Only 9 potential participants have refused trial participation. The median age of the 64 participants is 64 years (range 37-86 years). Most are unmarried (64%) and have a high school diploma or less (72%). Only 13 of the participants (20%) have no comorbidities. The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant, Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Allan De Toma, Kendrea D. Knight, Kathryn Weaver, Elizabeth Calhoun, Nestor F. Esnaola. Interim Recruitment Outcomes in an NCORP-Based Patient Navigation Trial for African Americans with Early Stage Lung Cancer. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr A72.