BackgroundThough financial hardship is a well‐documented adverse effect of standard‐of‐care cancer treatment, little is known about out‐of‐pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation.MethodsThis cross‐sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness. Surveys included questions on cancer clinical trial participation, trial‐related financial hardship, and sociodemographic data. Descriptive and bivariate analyses were conducted using Cramer's V to estimate the in‐sample magnitude of association. Associations between trial‐related financial hardship and sociodemographics were estimated using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors.ResultsOf 650 survey respondents, 18% (N = 118) reported ever participating in a cancer clinical trial. Of those, 47% (n = 55) reported financial hardship as a result of their trial participation. Respondents reporting trial‐related financial hardship were more often unemployed or disabled (58% vs. 43%; V = 0.15), Medicare enrolled (53% vs. 40%; V = 0.15), and traveled >1 h to their cancer provider (45% vs. 17%; V = 0.33) compared to respondents reporting no hardship. Respondents who experienced trial‐related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 h vs. ≤30 min to their cancer provider had a 2.2× higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR = 2.2, 95% CI 1.3–3.8). Most respondents (53%) reported needing $200–$1000 per month to compensate for trial‐related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a cancer clinical trial (n = 532), 13% declined participation due to cost.ConclusionCancer clinical trial‐related financial hardship, most often stemming from travel expenses, affected almost half of trial‐enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation.

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了解参与癌症临床试验的财务成本

背景尽管经济困难是标准护理癌症治疗的一个有据可查的不良影响，但人们对自付费用及其对参与癌症临床试验的患者的影响知之甚少。这项研究探讨了参与癌症临床试验的财务影响。方法这项横断面分析使用了 2022 年 12 月和 2023 年 5 月从患者倡导基金会 (Patient Advocate Foundation) 先前服务过的癌症患者收集的调查数据，该基金会是一个为美国提供社会需求导航和经济援助的非营利组织患有慢性病的成年人。调查包括有关癌症临床试验参与、试验相关的经济困难和社会人口统计数据的问题。使用 Cramer 进行描述性分析和双变量分析V估计样本内的关联程度。使用调整后的相对风险 (aRR) 和来自具有稳健标准误的修正泊松回归模型的相应 95% 置信区间 (CI) 来估计试验相关的财务困难和社会人口统计学之间的关联。结果在 650 名调查受访者中，18% (氮= 118) 报告曾参加过癌症临床试验。其中，47%（n= 55) 报告由于参与试验而陷入经济困难。报告与试验相关的经济困难的受访者往往失业或残疾（58% vs. 43%；V= 0.15), 参加医疗保险 (53% vs. 40%;V= 0.15），并且前往癌症提供者处的时间超过 1 小时（45% vs. 17%；V= 0.33）与报告没有困难的受访者相比。经历过与试验相关的经济困难的受访者最常报告的费用来自旅行（71％的受访者报告）、医疗费用（58％）、外出就餐（40％）或住房需求（40％）。建模结果表明，即使在对受访者的种族、收入、就业和保险状况进行调整后，受访者前往癌症提供者处的时间 >1 小时与 ≤30 分钟相比，其经济困难的风险要高 2.2 倍（aRR = 2.2，95% CI 1.3–3.8）。大多数受访者 (53%) 表示每月需要 200 至 1000 美元来补偿试验相关费用。超过一半（51%）的受访者表示由于经济困难而不太愿意参加未来的临床试验。值得注意的是，未参加癌症临床试验的患者（n= 532），13% 由于费用而拒绝参与。 结论 癌症临床试验相关的经济困难（最常见的是差旅费）影响了近一半的试验注册患者。需要采取干预措施来减少不利的财务参与影响并可能提高癌症临床试验的参与度。