title: Patient perceptions and willingness to participate in clinical trials.
abstract: To evaluate gynecologic oncology patients' perceptions and willingness to participate in randomized clinical trials (RCT) among an inner city population.
  
  
  
  Informed consent was obtained. Demographics were collected and willingness to participate in a RCT was measured by the Attitudes on Randomized Trials Questionnaire (ARTQ). The Hospital Anxiety and Depression Scale estimated levels of anxiety and depression. A Perception Survey was created and tested as a screening tool for patients considering RCTs. Standard statistical tests were used.
  
  
  
  One hundred and one women participated, 54 (53.5%) were black, 31 (30.7%) were white, non-Hispanic and 15 (14.9%) were Hispanic. Screening for anxiety and depression revealed an 18.8% rate of moderate to severe anxiety and an 11.9% rate of moderate to severe depression. Willingness to participate in a RCT as measured by ARTQ scores was not significantly associated with race, levels of anxiety or depression. Twenty-eight percent of women would agree to participate in a clinical trial at baseline. An additional, 33 (32.7%), for a total of 61.4%, indicated agreement after targeted education with no statistical differences by race or psychological stressor. However, sixty-one percent of these women were black. The Perception Survey approximated the results of the ARTQ with reasonable accuracy (AUC 0.758, p<0.001) CONCLUSIONS: Neither race nor psychological stressor were significant indicators of willingness to participate in a RCT. Targeted education resulted in a majority of patients indicating willingness to participate in trials, especially among black women. Additionally, a novel screening tool was tested and performed well in this setting.
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, Lewis Katz School of Medicine at Temple University & Fox Chase Cancer Center, Philadelphia, PA, United States. Electronic address: elenaigwe@gmail.com.
authors.forename: Elena
authors.initials: E
authors.lastname: Igwe
authors.affiliation: Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States.
authors.forename: Julie
authors.initials: J
authors.lastname: Woodburn
authors.affiliation: Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States.
authors.forename: Jacyln
authors.initials: J
authors.lastname: Davolos
authors.affiliation: Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States.
authors.forename: Cori
authors.initials: C
authors.lastname: Shollenberger
authors.affiliation: Fox Chase Cancer Center/ Temple University Health System, Philadelphia, PA, United States.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Miller
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, Lewis Katz School of Medicine at Temple University & Fox Chase Cancer Center, Philadelphia, PA, United States.
authors.forename: Enrique
authors.initials: E
authors.lastname: Hernandez
authors.affiliation: Department of Obstetrics, Gynecology & Reproductive Sciences, Lewis Katz School of Medicine at Temple University & Fox Chase Cancer Center, Philadelphia, PA, United States.
authors.forename: J Stuart
authors.initials: JS
authors.lastname: Ferriss
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005833:Genital Neoplasms, Female / Q000523:psychology* / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D008913:Minority Groups / Q000523:psychology; D010342:Patient Acceptance of Health Care / Q000523:psychology; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires
keywords: Minority participation; Participation in clinical trials; Willingness to participate in clinical trials