title: The Effect of Receiving Treatment Within a Clinical Trial Setting on Survival and Quality of Care Perception in Advanced Stage Non-Small Cell Lung Cancer.
abstract: OBJECTIVE
  Treatment outcomes of advanced stage (IIIB and IV) non-small cell lung cancer (NSCLC) are poor. In this study, we explore the survival outcomes and the perception of the quality of care delivered in stage IIIB and IV NSCLC patients treated within versus outside a clinical trial.
  
  
  METHODS
  Data were obtained from the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS). Baseline characteristics according to clinical trial participation were determined. The association between clinical trial enrollment and survival was assessed using a Cox proportional hazard model after adjusting for age, income, primary data collection and research site, comorbidities, self-reported performance status, presence of brain metastasis, stage IIIB versus IV, and cancer histology.
  
  
  RESULTS
  Of 815 stage IIIB and IV NSCLC patients, 56 (7%) were enrolled in clinical trials. Median survival for the patients treated within versus outside a clinical trial was 20.5 versus 16.7 months, respectively (P=0.21). Using a multivariate survival model, clinical trial enrollment did not correlate with longer survival (P=0.81). Comparing patients according to clinical trial enrollment, patients treated within a clinical trial setting perceived a better overall quality of care (P<0.01).
  
  
  CONCLUSIONS
  Management of stage IIIB and IV NSCLC patients within a clinical trial setting conveyed a perception of superior care that did not translate into survival benefit. These findings suggest that providing cancer care within a clinical trial should not imply a survival benefit when counseling stage IIIB and IV NSCLC patients about entering clinical trials.
authors.affiliation: *Department of Internal Medicine, Division of Hematology, Oncology, Blood & Marrow Transplantation, University of Iowa Hospitals and Clinics ‡Department of Internal Medicine and Program in Bioethics and Humanities, University of Iowa Hospitals and Clinics †University of Iowa Hospitals and Clinics §Department of Biostatistics, University of Iowa, Iowa City, IA.
authors.forename: Taher
authors.initials: T
authors.lastname: Abu-Hejleh
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Chrischilles
authors.forename: Thorvardur R
authors.initials: TR
authors.lastname: Halfdanarson
authors.forename: Christian
authors.initials: C
authors.lastname: Simon
authors.forename: Jane F
authors.initials: JF
authors.lastname: Pendergast
authors.forename: Dingfeng
authors.initials: D
authors.lastname: Jiang
authors.forename: Carmen J
authors.initials: CJ
authors.lastname: Smith
authors.forename: Aaron T
authors.initials: AT
authors.lastname: Porter
authors.forename: Knute D
authors.initials: KD
authors.lastname: Carter
authors.forename: Robert B
authors.initials: RB
authors.lastname: Wallace
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000523:psychology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010465:Perception; D016016:Proportional Hazards Models