Financial toxicity in early-phase cancer clinical trial participants

IF 6.1 2区医学 Q1 ONCOLOGY Cancer Pub Date : 2024-10-10 DOI:10.1002/cncr.35586

Sienna M. Durbin MD, Debra Lundquist PhD, RN, Andrea Pelletier MPH, Laura A. Petrillo MD, Viola Bame BS, Victoria Turbini MS, RN, Hope Heldreth BS, Kaitlyn Lynch BS, Mary Boulanger MD, Anh Lam DO, Casandra McIntyre BS, RN, MTS, Betty R. Ferrell PhD, RN, MA, CHPN, FAAN, FPCN, Rachel Jimenez MD, Dejan Juric MD, Ryan D. Nipp MD, MPH

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Abstract

Background

Little is known about financial toxicity in early-phase clinical trial (EP-CT) participants. This study sought to describe financial toxicity in EP-CT participants and assess associations with patient characteristics and patient-reported outcomes (PROs).

Methods

Prospectively enrolled EP-CT participants from were followed from April 2021 through January 2023. Participants completed the Comprehensive Score for Financial Toxicity (<26 = financial toxicity) at time of treatment. Quality of life (QOL), symptoms, coping, and resource concerns were surveyed. Associations of financial toxicity with patient characteristics, PROs, and clinical outcomes were explored.

Results

Of 261 eligible patients, 197 completed baseline assessments (75.5%, median age = 63.4 years [31.8-88.6], 57.4% female). Most common cancers were gastrointestinal (33.0%) and breast (20.8%). More than one third (34.0%) of patients reported financial toxicity. Patients with financial toxicity were more likely to be <65 years (70.2% vs 48.5%, p = .004), unemployed (45.5% vs 16.9%, p < .001), not have attended college (53.1% vs 26.4%, p = .002), and have income <$60,000 (59.7% vs 25.4%, p < .001). In adjusted models, patients with financial toxicity reported lower QOL (B = –6.66, p = .004) and acceptance (B = –0.78, p = .002), and increased self-blame (B = 0.87, p < .001). They were more likely to have concerns regarding housing (10.6% vs 2.3%, p = .025), bills (31.8% vs 3.8%, p < .001), food (9.1% vs 0.8%, p = .006), and employment (21.2% vs 1.5%, p < .001). There was no difference in time on trial (hazard ratio, 1.03; p = .860) or survival (hazard ratio, 1.16; p = .496).

Conclusions

More than one third of EP-CT participants reported financial toxicity. Factors associated with financial toxicity and demonstrated novel associations among financial toxicity with QOL, coping, and resource concerns were identified, highlighting the need to address financial toxicity among this population.

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早期癌症临床试验参与者的经济毒性。

背景：人们对早期临床试验（EP-CT）参与者的财务毒性知之甚少。本研究旨在描述 EP-CT 参与者的财务毒性，并评估其与患者特征和患者报告结果（PROs）之间的关联：从 2021 年 4 月到 2023 年 1 月，对前瞻性入组的 EP-CT 参与者进行随访。参与者完成了财务毒性综合评分（结果：261 名符合条件的患者中，197 人完成了该评分：在 261 名符合条件的患者中，197 人完成了基线评估（75.5%，中位年龄 = 63.4 岁 [31.8-88.6]，57.4% 为女性）。最常见的癌症是胃肠道癌（33.0%）和乳腺癌（20.8%）。超过三分之一（34.0%）的患者报告了经济毒性。有经济毒性的患者更有可能是结论：超过三分之一的 EP-CT 参与者报告了财务毒性。研究发现了与财务毒性相关的因素，并证明了财务毒性与 QOL、应对能力和资源问题之间的新型关联，突出了解决该人群财务毒性问题的必要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer 医学-肿瘤学

CiteScore

13.10

自引率

3.20%

发文量

480

审稿时长

2-3 weeks

期刊介绍： The CANCER site is a full-text, electronic implementation of CANCER, an Interdisciplinary International Journal of the American Cancer Society, and CANCER CYTOPATHOLOGY, a Journal of the American Cancer Society. CANCER publishes interdisciplinary oncologic information according to, but not limited to, the following disease sites and disciplines: blood/bone marrow; breast disease; endocrine disorders; epidemiology; gastrointestinal tract; genitourinary disease; gynecologic oncology; head and neck disease; hepatobiliary tract; integrated medicine; lung disease; medical oncology; neuro-oncology; pathology radiation oncology; translational research