心理社会癌症临床试验中不同患者的纳入与留存
Accrual and retention of diverse patients in psychosocial cancer clinical trials.
作者信息
Hanvey Grace Ann, Padron Adaixa, Kacel Elizabeth L, Cartagena Gabriel, Bacharz Kelsey C, McCrae Christina S, Robinson Michael E, Waxenberg Lori B, Antoni Michael H, Berry Richard B, Schultz Gregory S, Castagno Jacqueline, Pereira Deidre B
机构信息
Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.
Department of Psychology, University of Miami, Coral Gables, FL, USA.
出版信息
J Clin Transl Sci. 2022 Apr 1;6(1):e45. doi: 10.1017/cts.2022.380. eCollection 2022.
BACKGROUND
Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers.
METHODS
Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored.
RESULTS
No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation.
DISCUSSION
These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.
背景
少数族裔和老年患者在癌症临床试验（CCTs）中的代表性仍然不足。当前研究旨在探讨在两项针对妇科、胃肠道和胸段癌症的心理社会CCTs中，社会人口统计学方面在CCT兴趣、资格、入组、拒绝动机和退出方面的不平等情况。
方法
邀请患者参与两项干预措施之一：（1）一项随机对照试验（RCT），研究一种认知行为干预对手术后睡眠、疼痛、情绪、细胞因子和皮质醇的影响；或（2）一项瑜伽干预，以确定其可行性、可接受性以及对减轻痛苦的效果。对前瞻性RCT参与者询问其兴趣并进行资格筛查。向所有试验中的合格患者提供入组机会。拒绝瑜伽干预入组的患者提供拒绝理由。探讨入组决策和退出的社会人口统计学预测因素。
结果
未观察到RCT兴趣方面的社会人口统计学差异，老年患者更有可能不符合资格。各试验中的合格西班牙裔患者比非西班牙裔患者更有可能入组。社会人口统计学因素预测了拒绝动机的差异。在一项试验中，来自城市地区更多的个体更有可能过早停止参与。
讨论
这些结果证实了少数群体在CCT兴趣方面无显著差异的证据，老年成年人更不太可能符合资格标准。虽然西班牙裔的绝对入组人数不多，但相对于非西班牙裔患者，西班牙裔患者更有可能入组。在拒绝动机和退出的地理预测方面还注意到了其他社会人口统计学趋势。有必要进行进一步调查，以更好地理解代表性CCTs中的不平等、障碍和最佳招募做法。
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