Chemotherapy-Induced Peripheral Neuropathy (CIPN) Measurement Validation

 描述（由申请人提供）：今天生活在美国（US）的近1400万癌症幸存者中的大多数接受化疗，这是一种主要的癌症治疗方法。许多化疗药物具有神经毒性，几乎所有接受这些药物的患者都会发生化疗诱导的周围神经病变（CIPN）。常见的CIPN症状包括四肢麻木、刺痛和神经性疼痛。CIPN可能需要减少化疗剂量，从而可能影响癌症治疗效果。症状可变为慢性，功能残疾和生活质量下降是常见的不良后果。尽管有这些令人衰弱的后果，但研究人员一直无法找到有效的CIPN治疗方法，部分原因是CIPN测量的局限性。更具体地说，对于在干预研究中使用哪种CIPN测量方法没有共识。毒性分级量表，如美国国家癌症研究所不良事件通用术语标准（NCI-CTCAE）是当今CIPN干预研究中最常用的结局指标。然而，分级尺度一再被证明是不敏感和不可靠的。缺乏金标准措施限制了我们建立从一项研究到下一项研究所获得的知识的能力，并且不敏感的措施可能无法检测到真正有效的实验治疗所导致的CIPN的改善。因此，本研究将解决这两个问题：1）没有金标准的CIPN测量方法，2）心理测量弱措施通常用于测量CIPN治疗效果。解决这些CIPN测量问题是很重要的，因为它们对发现一个普遍和令人痛苦的问题的新疗法构成了障碍。本研究的长期目标是确定一个上级CIPN结果的措施，这将有助于在未来发现有效的CIPN治疗。为了实现这一目标，我们将进行二次数据分析，然后进行混合方法，前瞻性，纵向研究，以广泛检查有前途的CIPN患者报告结局指标（PRO）的心理测量学特性，欧洲癌症研究和治疗组织生活质量量表-化疗诱导的周围神经病变量表（QLQ-CIPN-20）。本研究的具体目的是评价QLQ-CIPN-20的信度、效度、敏感性和对变化的反应性。研究结果将具有高度的普遍性，并将对症状管理科学做出重大贡献，因为最终产品将是一个经过完善和充分测试的CIPN PRO措施。这项措施将准备用于未来的小规模和大规模研究，旨在发现有效的干预措施，以改善接受神经毒性化疗的个体的临床结局和生活质量。

 DESCRIPTION (provided by applicant): Most of the nearly 14 million cancer survivors living in the United States (US) today received chemotherapy, a mainstay cancer treatment. Many chemotherapy drugs are neurotoxic, and almost all who receive these drugs will develop chemotherapy-induced peripheral neuropathy (CIPN). Common CIPN symptoms include numbness, tingling, and neuropathic pain in the extremities. CIPN can necessitate chemotherapy dose reductions, potentially compromising cancer treatment efficacy. Symptoms can become chronic, and functional disability and diminished quality of life are common adverse outcomes. Despite these debilitating consequences, researchers have been unable to find effective CIPN treatments in part due to CIPN measurement limitations. More specifically, there is no consensus regarding which CIPN measurement approach to use in intervention studies. Toxicity grading scales such as the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) are the most commonly used outcome measures utilized in today's CIPN intervention research. However, grading scales have been repeatedly shown to be insensitive and unreliable. The lack of a gold-standard measure limits our ability to build upon the knowledge gained from one study to the next, and insensitive measures may not detect improvements in CIPN resulting from a truly effective experimental treatment. Thus, this research will address these two problems; 1) there is no gold-standard CIPN measurement approach, and 2) psychometrically weak measures are commonly used to measure CIPN treatment efficacy. It is important to address these CIPN measurement problems because they pose a barrier to discovering new treatments for a prevalent and distressing problem. The long-term goal of this research is to identify a superior CIPN outcome measure that will aid in the future discovery of effective CIPN treatments. To accomplish this goal, we will conduct a secondary data analysis followed by a mixed methods, prospective, longitudinal study to extensively examine the psychometric properties of a promising CIPN patient-reported outcome measure (PRO), the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN-20). The study Specific Aim is to evaluate QLQ-CIPN-20 reliability, validity, sensitivity, and responsiveness to change. The study results will be highly generalizable and will make a substantial contribution to symptom management science because the end product will be a refined and fully tested CIPN PRO measure. This measure will be ready for use in future small- and large-scale studies designed to uncover effective interventions to improve clinical outcomes and quality of life for individuals who receive neurotoxic chemotherapy.