title: Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program.
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  Financial barriers likely discourage patients from participating in clinical trials. Implementation of a cancer care equity program (CCEP) seeking to reduce financial barriers by assisting with travel and lodging costs was associated with increased trial accrual. The CCEP provided assistance to patients particularly in need, including those living farther away, those with lower incomes, and those reporting financial barriers related to trial participation. These findings suggest that financial concerns represent a major barrier to patient participation in clinical trials and underscore the importance of efforts to address these concerns.
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA RNipp@MGH.Harvard.edu.
authors.forename: Ryan D
authors.initials: RD
authors.lastname: Nipp
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Hang
authors.initials: H
authors.lastname: Lee
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Powell
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Nicole E
authors.initials: NE
authors.lastname: Birrer
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Poles
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Finkelstein
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Winkfield
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Sanja
authors.initials: S
authors.lastname: Percac-Lima
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Chabner
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Moy
mesh_terms: D000368:Aged; D005260:Female; D006297:Health Services Accessibility / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000191:economics* / Q000453:epidemiology* / Q000473:pathology; D010358:Patient Participation / Q000191:economics; D018579:Patient Selection; D011203:Poverty / Q000191:economics; D011795:Surveys and Questionnaires
keywords: Clinical trial; Cost of illness; Financial support; Health care costs; Quality of life