Patient perceptions and willingness to participate in clinical trials

Elena Igwe, Julie Woodburn, Jacyln Davolos, Cori Shollenberger, Suzanne M. Miller, Enrique Hernandez, Stuart Ferriss

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objective To evaluate gynecologic oncology patients’ perceptions and willingness to participate in randomized clinical trials (RCT) among an inner city population. Methods 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. Results 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.

Original languageEnglish (US)
Pages (from-to)520-524
Number of pages5
JournalGynecologic Oncology
Volume142
Issue number3
DOIs
StatePublished - Sep 1 2016

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Anxiety
Clinical Trials
Depression
Randomized Controlled Trials
Psychology
Education
Informed Consent
Hispanic Americans
Area Under Curve
Demography
Surveys and Questionnaires
Population

Keywords

  • Minority participation
  • Participation in clinical trials
  • Willingness to participate in clinical trials

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Igwe, E., Woodburn, J., Davolos, J., Shollenberger, C., Miller, S. M., Hernandez, E., & Ferriss, S. (2016). Patient perceptions and willingness to participate in clinical trials. Gynecologic Oncology, 142(3), 520-524. https://doi.org/10.1016/j.ygyno.2016.06.015

Patient perceptions and willingness to participate in clinical trials. / Igwe, Elena; Woodburn, Julie; Davolos, Jacyln; Shollenberger, Cori; Miller, Suzanne M.; Hernandez, Enrique; Ferriss, Stuart.

In: Gynecologic Oncology, Vol. 142, No. 3, 01.09.2016, p. 520-524.

Research output: Contribution to journalArticle

Igwe, E, Woodburn, J, Davolos, J, Shollenberger, C, Miller, SM, Hernandez, E & Ferriss, S 2016, 'Patient perceptions and willingness to participate in clinical trials', Gynecologic Oncology, vol. 142, no. 3, pp. 520-524. https://doi.org/10.1016/j.ygyno.2016.06.015
Igwe E, Woodburn J, Davolos J, Shollenberger C, Miller SM, Hernandez E et al. Patient perceptions and willingness to participate in clinical trials. Gynecologic Oncology. 2016 Sep 1;142(3):520-524. https://doi.org/10.1016/j.ygyno.2016.06.015
Igwe, Elena ; Woodburn, Julie ; Davolos, Jacyln ; Shollenberger, Cori ; Miller, Suzanne M. ; Hernandez, Enrique ; Ferriss, Stuart. / Patient perceptions and willingness to participate in clinical trials. In: Gynecologic Oncology. 2016 ; Vol. 142, No. 3. pp. 520-524.
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abstract = "Objective To evaluate gynecologic oncology patients’ perceptions and willingness to participate in randomized clinical trials (RCT) among an inner city population. Methods 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. Results 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.",
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