title: Does phase 1 trial enrollment preclude quality end-of-life care? Phase 1 trial enrollment and end-of-life care characteristics in children with cancer.
abstract: BACKGROUND
  End-of-life care (EOLC) discussions and treatment-related decisions, including phase 1 trial enrollment, in patients with incurable disease are complex and can influence the quality of EOLC received. The current study was conducted in pediatric oncology patients to determine whether end-of-life characteristics differed between those who were and were not enrolled in a phase 1 trial.
  
  
  METHODS
  The authors reviewed the medical records of 380 pediatric oncology patients (aged <22 years at the time of death) who died during a 3.5-year period. Of these, 103 patients with hematologic malignancies were excluded. A total of 277 patients with a diagnosis of a brain tumor or other solid tumor malignancy were divided into 2 groups based on phase 1 trial enrollment: a phase 1 cohort (PIC; 120 patients) and a non-phase 1 cohort (NPIC; 157 patients). The EOLC characteristics of these 2 cohorts were compared using regression analysis and chi-square testing.
  
  
  RESULTS
  A comparison of patients in the PIC and NPIC revealed no significant differences in either demographic characteristics (including sex, race, religious affiliation, referral origin, diagnosis, or age at diagnosis, with the exception of age at the time of death [P =.03]) or in EOLC indices (such as use or timing of do not attempt resuscitation orders, hospice use or length of stay, forgoing life-sustaining therapies, location of death, time from first EOLC discussion to death, and total number of EOLC discussions).
  
  
  CONCLUSIONS
  The results of the current study of a large cohort of deceased pediatric cancer patients indicate that enrollment on a phase 1 trial does not affect EOLC characteristics, suggesting that quality EOLC can be delivered regardless of phase 1 trial participation.
authors.affiliation: Division of Quality of Life and Palliative Care, Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Deena R
authors.initials: DR
authors.lastname: Levine
authors.forename: Liza-Marie
authors.initials: LM
authors.lastname: Johnson
authors.forename: Belinda N
authors.initials: BN
authors.lastname: Mandrell
authors.forename: Jie
authors.initials: J
authors.lastname: Yang
authors.forename: Nancy K
authors.initials: NK
authors.lastname: West
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Hinds
authors.forename: Justin N
authors.initials: JN
authors.lastname: Baker
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D011787:Quality of Health Care; D011788:Quality of Life; D013727:Terminal Care / Q000592:standards*
chemical_list: D000970:Antineoplastic Agents
keywords: end-of-life care; oncology; pediatric oncology; phase 1 clinical trials