title: Application of best practice approaches for designing decision support tools: the preparatory education about clinical trials (PRE-ACT) study.
abstract: OBJECTIVE
  This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials.
  
  
  METHODS
  The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group (N=100) from the randomized trial.
  
  
  RESULTS
  Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool's user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos.
  
  
  CONCLUSIONS
  The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process. Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools.
authors.affiliation: Children's Hospital of Philadelphia, USA; Fox Chase Cancer Center/Temple University Health System, USA. Electronic address: fleisherl@chop.edu.
authors.forename: Linda
authors.initials: L
authors.lastname: Fleisher
authors.affiliation: St. Joseph's University, USA.
authors.forename: Dominique G
authors.initials: DG
authors.lastname: Ruggieri
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Miller
authors.affiliation: Cancer Institute of New Jersey, USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Manne
authors.affiliation: Karmanos Cancer Institute, Department of Oncology, Wayne State University, USA.
authors.forename: Terrance
authors.initials: T
authors.lastname: Albrecht
authors.affiliation: Cancer Support Community, USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Buzaglo
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Collins
authors.affiliation: International Myeloma Foundation, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Katz
authors.affiliation: University Hospitals Case Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, USA.
authors.forename: Tyler G
authors.initials: TG
authors.lastname: Kinzy
authors.affiliation: University Hospitals Case Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, USA.
authors.forename: Tasnuva
authors.initials: T
authors.lastname: Liu
authors.affiliation: Triad Interactive, USA.
authors.forename: Cheri
authors.initials: C
authors.lastname: Manning
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Ellen Specker
authors.initials: ES
authors.lastname: Charap
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Millard
authors.affiliation: University Hospitals Case Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, USA.
authors.forename: Dawn M
authors.initials: DM
authors.lastname: Miller
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: David
authors.initials: D
authors.lastname: Poole
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Raivitch
authors.affiliation: Fight Colorectal Cancer, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Roach
authors.affiliation: Fox Chase Cancer Center/Temple University Health System, USA.
authors.forename: Eric A
authors.initials: EA
authors.lastname: Ross
authors.affiliation: University Hospitals Case Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, USA.
authors.forename: Neal J
authors.initials: NJ
authors.lastname: Meropol
mesh_terms: D019985:Benchmarking; D002986:Clinical Trials as Topic; D003657:Decision Making; D020000:Decision Support Systems, Clinical / Q000458:organization & administration*; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000628:therapy*; D010348:Patient Care Team / Q000458:organization & administration; D010353:Patient Education as Topic / Q000379:methods; D010358:Patient Participation / Q000379:methods*; D018802:Patient-Centered Care / Q000458:organization & administration
keywords: Cancer; Clinical trials; Decision aids; Decision support tools