title: Effects of a brief multimedia psychoeducational intervention on the attitudes and interest of patients with cancer regarding clinical trial participation: a multicenter randomized controlled trial.
abstract: OBJECTIVE
  The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials.
  
  
  METHODS
  A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later.
  
  
  RESULTS
  Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials.
  
  
  CONCLUSIONS
  A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials.
authors.affiliation: Moffitt Cancer Centerand University of South Florida, Tampa, FL, USA. paul.jacobsen@moffitt.org
authors.forename: Paul B
authors.initials: PB
authors.lastname: Jacobsen
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Wells
authors.forename: Cathy D
authors.initials: CD
authors.lastname: Meade
authors.forename: Gwendolyn P
authors.initials: GP
authors.lastname: Quinn
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: William J
authors.initials: WJ
authors.lastname: Fulp
authors.forename: Jhanelle E
authors.initials: JE
authors.lastname: Gray
authors.forename: Rachid C
authors.initials: RC
authors.lastname: Baz
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Springett
authors.forename: Richard M
authors.initials: RM
authors.lastname: Levine
authors.forename: Merry-Jennifer
authors.initials: MJ
authors.lastname: Markham
authors.forename: Fred J
authors.initials: FJ
authors.lastname: Schreiber
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Cartwright
authors.forename: James M
authors.initials: JM
authors.lastname: Burke
authors.forename: Robert D
authors.initials: RD
authors.lastname: Siegel
authors.forename: Mokenge P
authors.initials: MP
authors.lastname: Malafa
authors.forename: Daniel
authors.initials: D
authors.lastname: Sullivan
mesh_terms: D000368:Aged; D001290:Attitude; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019212:Multimedia; D009369:Neoplasms / Q000523:psychology*; D010353:Patient Education as Topic / Q000379:methods*; D010358:Patient Participation