Lazarex Cancer Foundation

PURPOSE:Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment.METHODS:Study participants for this study were recruited at two National Cancer Institute–designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials.RESULTS:The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%).CONCLUSION:The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.

166 Background: The degree to which cancer caused financial problems may influence ca pts par in cts and negatively impact quality of life (QoL). Financial burden of cts par, may include finding an appropriate trial, traveling to the trial site, paying for travel, lodging and some medical expenses. The Lazarex Cancer Foundation (LCF) was founded in 2006 with mission to improve care, giving hope, dignity, and life to advanced ca pts by providing assistance with options and costs to cts par, community outreach, and education. LCF developed processes to removing the barriers to cts par by improving equitable access to cancer care, increasing cts enrollment, retention and minority par, and increasing cts referrals. Methods: To determine the extent of benefit of LCF, we conducted a retrospective analysis of LCF beneficiaries participating in cts by reviewing and summarizing the #pts, states and countries of residence, age, type of cancer, location and distance to cts site, type of assistance, and #of advocacy/outreach. Results: From 1/01/2010 – 12/31/2015 1479 pts were assisted; age range 4-86 yrs, median 50-60; 638(43%) male, 790 (53%) female, 51 (3.4%) undeclared. 434 did not give racial/ethnic identity; of 1045, 67 (6.4%) were African American, 108 (10.3%) Hispanic, 38 (3.6) Asian Pacific Islander, other 22 (2.1), and Caucasian 760 (72.7%) –total minority 235 (22.5%). Pts resided in 49 states with largest CA-280, TX-131, MA-119, FL-81. Cts were at 115 sites; 38 NCI CCC, 8 NCI DCC. The most common diagnoses were breast-116, leukemia-87, colorectal-48 and many rare type tumors. The median household income was $75,000. Financial assistance to travel to and living expenses at the cts site was the most frequently identified need. Conclusions: Relieving pts of financial burden allows greater access to and participation in cancer clinical trials. Further research and greater resources are needed to define the patient needs and determine methods to eliminate and remove barriers to enrollment and retention. Future research should investigate coverage thresholds that minimize adverse financial outcomes and identify ca pts at greatest risk for financial toxicity to increase par in cts and enhance QoL.