PO.CL04.02 · 临床研究
科学与讲故事:运用多组分循证策略成功招募高危子宫内膜癌黑人女性参加SISTER研究
Science and Storytelling: Using a multi-component evidenced based strategy for successful recruitment of Black women with high-risk endometrial cancer to The SISTER Study
该海报暂无可下载的资料
AACR 官方页面
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
引言:黑人女性在全国随机临床试验中代表性不足。为解决已知的入组结构性和人际障碍并进行准确的招募规划,需要从筛查到随机化的详细入组统计数据。
方法:子宫内膜癌治疗与复发的社会支持干预(SISTER)研究是一项13个中心的全国性随机试验,招募了在诊断确认与治疗开始之间的时间窗内入组的高危EC黑人/非裔美国女性。在一个与黑人EC幸存者共同参与的社区参与式过程中,我们创建了一套新颖的多组分循证招募与入组流程,以加强招募和入组,并在所有SISTER研究中心部署。我们与黑人EC癌症倡导团体ECANA合作,创建了聚焦于社区建设和治疗期间自我赋能的印刷及网络入组材料。我们还制作了一段入组视频,视频中主要研究者(PI)和黑人EC幸存者分享了关于EC种族差异及本研究重要性的个人故事,同时配以随机化和干预组的图形展示。运用"早期联系"和"候诊室"策略,我们在参与者首次肿瘤科就诊时或之前识别他们,并在其符合资格窗口之前数天至数周发起现场对话。所有被考虑纳入研究的参与者均被前瞻性地记录并登记在研究门户中,从而能够准确报告筛查和入组率。
结果:从2021年9月至2025年9月,识别出609人,正式筛查了540人。在接受筛查者中,31%(n=166)根据临床和非临床排除标准不符合资格。在剩余的374人中,16%(n=59)拒绝被接洽。在315名接受知情同意接洽者中,85%(n=269)同意,13%(n=46)拒绝。试验入组目标252人得以实现,占所有识别人数的41%、正式筛查人数的47%、符合资格者的67%以及接受知情同意接洽者的80%。
结论:当被接洽并被邀请参与时,高危EC黑人女性选择了入组一项随机对照干预试验。运用循证的社区参与式策略,我们成功招募了这一长期代表性不足、在狭窄资格窗口内需要接受积极治疗的群体。我们的入组率可用于准确规划黑人女性在子宫内膜癌试验中的适当代表性,而这一多组分策略可在全国范围内使用,以提高历史上被排除社区的公平临床试验代表性。
查看英文原文 English abstract
Introduction: Black women are underrepresented in national randomized clinical trials. To address known structural and interpersonal barriers to enrollment and for accurate recruitment planning, detailed enrollment statistics from screening to randomization are needed.
Methods: The Social Interventions for Support in Endometrial Cancer Treatment and Recurrence (SISTER) Study is a 13-site national randomized trial that recruited Black/African American women with high-risk EC who were enrolled in the time window between diagnostic confirmation and treatment initiation. In a community-engaged process with Black EC survivors, we created a novel multi-component, evidenced-based recruitment and enrollment process to enhance recruitment and enrollment that was deployed at all SISTER Study sites. In partnership with ECANA, a Black EC cancer advocacy group, we created print and web enrollment materials focused on community-building and self-empowerment during treatment. We also developed an enrollment video that featured the PI and Black EC survivors sharing personal stories about the racial disparities in EC and the importance of the study alongside graphic depictions of randomization and intervention arms. Using an ‘early contact' and ‘waiting room' strategy, we identified participants at or prior to their first oncology visit and initiated live conversations occurring several days to weeks prior to their eligibility window. All participants considered for the study were prospectively captured and logged in the study portal allowing for accurate reporting on screening and enrollment rates.
Results: From September 2021 to September 2025, 609 individuals were identified, and 540 officially screened for the trial. Of those screened, 31% (n=166) were ineligible based on clinical and non-clinical exclusion criteria. Of the remaining 374, 16% (n=59) declined being approached. Of the 315 approached for consent, 85% (n=269) consented and 13% (n=46) declined. The trial enrollment goal of 252 was met, representing 41% of all identified, 47% of those official screened, 67% of those eligible, and 80% of those approached for consent.
Conclusions: When approached and invited to participate, Black women with high-risk EC chose to enroll in a randomized controlled interventional trial. Using evidenced-based community-engaged strategies, we successfully enrolled this long-standing underrepresented group requiring active treatment during a narrow eligibility window. Our enrollment rates can be used to accurately plan for appropriate representation of Black women in endometrial cancer trials, and the multi-component strategy can be used nationally to increase equitable clinical trial representation across historically excluded communities.
利益披露 Disclosure
K. M. Doll,
Merck ).
J. Alson, None.
A. Moore,
Eisai ).
AstraZeneka ).
A. Ngouonga, None..
P. Williams, None..
L. Sage, None..
B. Comstock, None..
S. Monsell, None.