title: A stakeholder-driven approach to improve the informed consent process for palliative chemotherapy.
abstract: OBJECTIVE
  Patients often anticipate cure from palliative chemotherapy. Better resources are needed to convey its risks and benefits. We describe the stakeholder-driven development and acceptability testing of a prototype video and companion booklet supporting informed consent (IC) for a common palliative chemotherapy regimen.
  
  
  METHODS
  Our multidisciplinary team (researchers, advocates, clinicians) employed a multistep process of content development, production, critical evaluation, and iterative revisions. Patient/clinician stakeholders were engaged throughout using stakeholder advisory panels, featuring their voices within the intervention, conducting surveys and qualitative interviews. A national panel of 57 patient advocates, and 25 oncologists from nine US practices critiqued the intervention and rated its clarity, accuracy, balance, tone, and utility. Participants also reported satisfaction with existing chemotherapy IC materials.
  
  
  RESULTS
  Few oncologists (5/25, 20%) or advocates (10/22, 45%) were satisfied with existing IC materials. In contrast, most rated our intervention highly, with 89-96% agreeing it would be useful and promote informed decisions. Patient voices were considered a key strength. Every oncologist indicated they would use the intervention regularly.
  
  
  CONCLUSIONS
  Our intervention was acceptable to advocates and oncologists. A randomized trial is evaluating its impact on the chemotherapy IC process.
  
  
  CONCLUSIONS
  Stakeholder-driven methods can be valuable for developing patient educational interventions.
authors.affiliation: McGraw Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: andrea_enzinger@dfci.harvard.edu.
authors.forename: Andrea C
authors.initials: AC
authors.lastname: Enzinger
authors.affiliation: McGraw Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Wind
authors.affiliation: Susan F. Smith Center for Women's Cancers, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Frank
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Nadine J
authors.initials: NJ
authors.lastname: McCleary
authors.affiliation: Colon Cancer Alliance, Washington, DC, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Porter
authors.affiliation: Department of Nursing, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Cushing
authors.affiliation: Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.
authors.forename: Caroline
authors.initials: C
authors.lastname: Abbott
authors.affiliation: McGraw Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Cronin
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Enzinger
authors.affiliation: Division of Hematology and Oncology, University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
authors.forename: Neal J
authors.initials: NJ
authors.lastname: Meropol
authors.affiliation: McGraw Patterson Center for Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010166:Palliative Care; D010174:Pamphlets; D010353:Patient Education as Topic; D010358:Patient Participation; D011379:Prognosis; D058996:Quality Improvement; D014741:Video Recording
keywords: Cancer chemotherapy; Informed consent; Palliative care; Patient-centered communication; Prognosis communication; Video intervention