Caston Nicole E, Deng Luqin, Williams Courtney P, Levitan Emily B, Azuero Andres, Griffin Russell, Smith Karen L, Wolff Antonio C, Melisko Michelle E, Shinn Eileen H, Gallagher Kathleen, Angove Rebekah, Wheeler Stephanie B, Rocque Gabrielle B
Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham (UAB), Birmingham, Alabama, USA.
Department of Epidemiology, UAB, Birmingham, Alabama, USA.
Cancer Med. 2025 Aug;14(16):e71010. doi: 10.1002/cam4.71010.
Although breast cancer (BC) clinical trials offer novel treatments, participating patients often do not represent populations seen in clinics. This study assessed how patient sociodemographics, attitudes, and knowledge about clinical trials may be associated with participation.
This cross sectional analysis used survey data collected August-September 2021 by Translational Breast Cancer Research Consortium (TBCRC) and December 2022 by Patient Advocate Foundation (PAF) among women with a BC diagnosis. Respondents reported BC clinical trial participation, Attitudes Toward Cancer Trials Scale, clinical trial knowledge, diagnosis age, race, education level, household income, employment status, and BC stage. Descriptive and bivariate analyses were conducted using Cramer's V or Cohen's d as effect sizes. Standardized total effects (b) were estimated using a prespecified Structural Equation Model with 0.1, 0.3, and 0.5 indicating weak, medium, and large magnitude, respectively.
Of 612 respondents, 26% were Black, Indigenous, or a Person of Color, 44% < Bachelor's degree, and 48% had incomes < $50,000. Respondents who reported trial participation (18%) more often had positive attitudes toward trials (mean 94 of 126, SD 19.3 vs. 86, SD 15.5; d = 0.48) compared to those not reporting participation. Positive attitude was associated with trial participation for both survey cohorts (TBCRC: b = 0.22, p = 0.0002; PAF: b = 0.13, p = 0.01). Furthermore, clinical trial knowledge was associated with attitudes (TBCRC: b = 0.27, p = < 0.0001; PAF: b = 0.15, p = 0.003).
Although we found that positive attitudes and high knowledge were associated with clinical trial participation, it is unknown if the trial itself directly affected this. However, trial enrollment may be increased and diversified via future interventions focused on promotion of positive attitudes toward clinical trials, potentially through increased trial education and knowledge.
尽管乳腺癌（BC）临床试验提供了新的治疗方法，但参与试验的患者往往不能代表临床中所见的人群。本研究评估了患者的社会人口统计学特征、态度以及对临床试验的了解程度与参与情况之间可能存在的关联。
这项横断面分析使用了转化乳腺癌研究联盟（TBCRC）于2021年8月至9月以及患者权益倡导基金会（PAF）于2022年12月收集的针对乳腺癌确诊女性的调查数据。受访者报告了其参与乳腺癌临床试验的情况、癌症试验态度量表得分、临床试验知识、诊断年龄、种族、教育水平、家庭收入、就业状况以及乳腺癌分期。使用克莱姆V系数或科恩d系数作为效应量进行描述性和双变量分析。使用预先设定的结构方程模型估计标准化总效应（b），其中0.1、0.3和0.5分别表示弱、中、大效应量。
在612名受访者中，26%为黑人、原住民或有色人种，44%拥有低于学士学位，48%的家庭收入低于50,000美元。报告参与试验的受访者（18%）对试验的态度往往更为积极（平均126分中的94分，标准差19.3，而未参与报告的受访者平均分为86分，标准差15.5；d = 0.48）。对于两个调查队列，积极态度均与试验参与相关（TBCRC：b = 0.22，p = 0.0002；PAF：b = 0.13，p = 0.01）。此外，临床试验知识与态度相关（TBCRC：b = 0.27，p = < 0.0001；PAF：b = 0.15，p = 0.003）。
尽管我们发现积极态度和丰富知识与临床试验参与相关，但尚不清楚试验本身是否直接影响了这一点。然而，未来可能通过侧重于促进对临床试验的积极态度的干预措施，可能是通过增加试验教育和知识，来提高试验入组率并使其多样化。
