Elena Igwe1, Julie Woodburn2, Jacyln Davolos2, Cori Shollenberger2, Suzanne M Miller3, Enrique Hernandez4, J Stuart Ferriss4. 1. 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. 2. Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States. 3. Fox Chase Cancer Center/ Temple University Health System, Philadelphia, PA, United States. 4. Department of Obstetrics, Gynecology & Reproductive Sciences, Lewis Katz School of Medicine at Temple University & Fox Chase Cancer Center, Philadelphia, PA, United States.
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.
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.
Authors: Shiyu Jiang; Peng Liu; Sheng Yang; Jianliang Yang; Dawei Wu; Hong Fang; Yan Qin; Shengyu Zhou; Jianping Xu; Yongkun Sun; Hongnan Mo; Lin Gui; Puyuan Xing; Bo Lan; Bo Zhang; Le Tang; Yan Sun; Yuankai Shi Journal: BMJ Open Date: 2019-06-01 Impact factor: 2.692
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