Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program. (14th March 2016) - Nipp, Ryan D.
Abstract: Introduction: Cancer clinical trial (CT) participation rates are low and financial barriers likely play a role. We implemented a cancer care equity program (CCEP) to address financial burden associated with trial participation. We sought to examine the impact of the CCEP on CT enrollment and to assess barriers to participation. Methods: We used an interrupted time series design to determine trends in CT enrollment before and after CCEP implementation. Linear regression models compared trial enrollment before and after the CCEP. We also compared patient characteristics before and after the CCEP and between CCEP and non-CCEP participants. We surveyed CCEP and non-CCEP participants to compare pre-enrollment financial barriers. Results: After accounting for increased trial availability and the trends in accrual for prior years, we found that enrollment increased after CCEP implementation (18.97 participants per month greater than expected; p < .001). A greater proportion of CCEP participants were younger, female, in phase I trials, lived farther away, had lower incomes, and had metastatic disease. Of 87 participants who completed the financial barriers survey, 49 CCEP and 38 matched, non-CCEP participants responded (63% response rate). CCEP participants were more likely to report concerns regarding finances (56% vs. 11%), medical costs (47% vs. 14%), travel (69% vs. 11%), lodging (60% vs. 9%), and insurance coverage (43% vs. 14%) related to trial participation (all p < .01). Conclusion: CT participation increased following implementation of the CCEP and the program enrolled patients experiencing greater financial burden. These findings highlight the need to address the financial burden associated with CT participation. Abstract : This study found that after implementation of a cancer care equity program (CCEP), cancer clinical trial enrollment increased. A greater proportion of CCEP participants were younger, female, and in phase I trials, lived farther away from the trial site, and had lower incomes and metastatic disease. CCEP participants were more likely than those not enrolled to report concerns regarding finances, medical costs, travel, lodging, and insurance coverage related to trial participation.