title: Practical communication guidance to improve phase 1 informed consent conversations and decision-making in pediatric oncology.
abstract: BACKGROUND
  It can be difficult to explain pediatric phase 1 oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions.
  
  
  METHODS
  Suggestions for improving the informed consent process were first solicited from phase 1 study clinicians via questionnaire. Eight parents who had enrolled their child on a phase 1 pediatric oncology trial were recruited for an advisory group designed to assess the clinicians' suggestions and make additional recommendations for improving informed consent for pediatric phase 1 trials.
  
  
  RESULTS
  A phase 1 communication model was designed to incorporate the suggestions of clinicians and families. It focused on educating parents/families about phase 1 trials at specific time points during a child's illness, but specifically at the point of disease recurrence. An informative phase 1 fact sheet that can be distributed to families was also presented.
  
  
  CONCLUSIONS
  Families who will be offered information regarding phase 1 clinical trials can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be enhanced further when oncologists address key themes, beginning at the time of diagnosis and continuing through important decision points during the child's illness. This model should be prospectively evaluated.
authors: Division of Quality of Life and Palliative Care, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors: Liza-Marie
authors: LM
authors: Johnson
authors: Department of Bioethics, Cleveland Clinic, Cleveland, Ohio.
authors: Angela C
authors: AC
authors: Leek
authors: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors: Dennis
authors: D
authors: Drotar
authors: Division of Developmental and Behavioral Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.
authors: Robert B
authors: RB
authors: Noll
authors: Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors: Susan R
authors: SR
authors: Rheingold
authors: Center for Ethics, Humanities, and Spiritual Care, Cleveland Clinic, Cleveland, Ohio.
authors: Eric D
authors: ED
authors: Kodish
authors: Division of Quality of Life and Palliative Care, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors: Justin N
authors: JN
authors: Baker
mesh_terms: D000328:Adult; D002648:Child; D003142:Communication; D032882:Comprehension; D003657:Decision Making; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D033282:Parental Consent; D010372:Pediatrics; D010819:Physician's Role; D011795:Surveys and Questionnaires
keywords: ethics; patient perspectives; pediatric oncology; physician communication