Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, United States of America.
Department of Obstetrics and Gynecology, University of Virginia, Charlottesville, VA, United States of America.
Gynecol Oncol. 2020 May;157(2):323-328. doi: 10.1016/j.ygyno.2020.01.040. Epub 2020 Apr 3.
Given the disparity that exists in enrollment of minorities to oncology clinical trials, the objective of our study was to assess whether race is associated with willingness to participate in gynecologic oncology clinical trials in a rural Southern academic medicine setting. Our secondary aim was to determine whether willingness to participate is impacted by an educational intervention.
A single institution prospective survey study was performed at an academic medical center. Women presenting to the gynecologic oncology clinic with a current or prior diagnosis of gynecologic malignancy were approached to participate. The validated Attitudes to Randomized Trials Questionnaire (ARTQ) assessed willingness to participate in clinical trials. Relevant demographic and clinical data were abstracted. Characteristics were compared between those willing and unwilling to participate in clinical trials with a chi-square test for categorical variables and Wilcoxon rank sum tests for continuous data.
We enrolled 156 participants (50% White, 50% non-White) from May 2017 to January 2018. The minority group included 35% non-Hispanic Black, 9% Hispanic, 4% Asian, and 2% other. Median age was 63 years with endometrial cancer being the most common diagnosis (48%). On initial screen, only 35% were willing to participate in a clinical trial. Willingness to participate did not differ between race, age, marital status, education level, cancer type, stage, or mode of treatment. Rates improved to 82% after being provided additional educational information. Following education, White women and those with more education were significantly more willing to participate in clinical trials than their minority and less educated counterparts.
Willingness to participate improved among all sub-categories following an educational intervention. The increase in willingness was less robust among racial and ethnic minorities, suggesting that different tools are needed for recruitment of minorities to gynecologic oncology clinical trials.
鉴于少数族裔参与肿瘤学临床试验的差距,我们的研究目的是评估在南方农村学术医学环境中,种族是否与参与妇科肿瘤学临床试验的意愿相关。我们的次要目的是确定教育干预是否会影响参与意愿。
在一家学术医疗中心进行了一项单机构前瞻性调查研究。向在妇科肿瘤科诊所就诊的、当前或之前诊断为妇科恶性肿瘤的女性提出参与研究的邀请。采用经过验证的随机临床试验态度问卷(ARTQ)评估参与临床试验的意愿。提取相关人口统计学和临床数据。使用卡方检验比较分类变量和 Wilcoxon 秩和检验比较连续数据,比较愿意和不愿意参与临床试验的患者特征。
我们于 2017 年 5 月至 2018 年 1 月期间招募了 156 名参与者(50%为白人,50%为非白人)。少数民族组包括 35%的非西班牙裔黑人、9%的西班牙裔、4%的亚洲人和 2%的其他族裔。中位年龄为 63 岁,最常见的诊断是子宫内膜癌(48%)。在初次筛查时,只有 35%的人愿意参与临床试验。种族、年龄、婚姻状况、教育水平、癌症类型、分期或治疗方式与参与意愿无关。在提供额外的教育信息后,参与意愿率提高到 82%。在接受教育后,白人和受过更多教育的人比少数民族和受教育程度较低的人更愿意参与临床试验。
在进行教育干预后,所有亚组的参与意愿都有所提高。在种族和族裔少数群体中,参与意愿的增加幅度较小,这表明需要针对少数群体招募到妇科肿瘤学临床试验的不同工具。