title: The relationships among knowledge, self-efficacy, preparedness, decisional conflict, and decisions to participate in a cancer clinical trial.
abstract: BACKGROUND
  Cancer clinical trials (CCTs) are important tools in the development of improved cancer therapies; yet, participation is low. Key psychosocial barriers exist that appear to impact a patient's decision to participate. Little is known about the relationship among knowledge, self-efficacy, preparation, decisional conflict, and patient decisions to take part in CCTs.
  
  
  OBJECTIVE
  The purpose of this study was to determine if preparation for consideration of a CCT as a treatment option mediates the relationship between knowledge, self-efficacy, and decisional conflict. We also explored whether lower levels of decisional conflict are associated with greater likelihood of CCT enrollment.
  
  
  METHODS
  In a pre-post test intervention study, cancer patients (N = 105) were recruited before their initial consultation with a medical oncologist. A brief educational intervention was provided for all patients. Patient self-report survey responses assessed knowledge, self-efficacy, preparation for clinical trial participation, decisional conflict, and clinical trial participation.
  
  
  RESULTS
  Preparation was found to mediate the relationship between self-efficacy and decisional conflict (p = 0.003 for a test of the indirect mediational pathway for the decisional conflict total score). Preparation had a more limited role in mediating the effect of knowledge on decisional conflict. Further, preliminary evidence indicated that reduced decisional conflict was associated with increased clinical trial enrollment (p = 0.049).
  
  
  CONCLUSIONS
  When patients feel greater CCT self-efficacy and have more knowledge, they feel more prepared to make a CCT decision. Reduced decisional conflict, in turn, is associated with the decision to enroll in a clinical trial. Our results suggest that preparation for decision-making should be a target of future interventions to improve participation in CCTs.
authors.affiliation: Fox Chase Cancer Center, Philadelphia, PA 19111, USA. Suzanne.Miller@fccc.edu
authors.forename: S M
authors.initials: SM
authors.lastname: Miller
authors.forename: S V
authors.initials: SV
authors.lastname: Hudson
authors.forename: B L
authors.initials: BL
authors.lastname: Egleston
authors.forename: S
authors.initials: S
authors.lastname: Manne
authors.forename: J S
authors.initials: JS
authors.lastname: Buzaglo
authors.forename: K
authors.initials: K
authors.lastname: Devarajan
authors.forename: L
authors.initials: L
authors.lastname: Fleisher
authors.forename: J
authors.initials: J
authors.lastname: Millard
authors.forename: N
authors.initials: N
authors.lastname: Solarino
authors.forename: J
authors.initials: J
authors.lastname: Trinastic
authors.forename: N J
authors.initials: NJ
authors.lastname: Meropol
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic / Q000523:psychology*; D003220:Conflict, Psychological; D003657:Decision Making; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D010353:Patient Education as Topic / Q000379:methods; D018579:Patient Selection; D020377:Self Efficacy