Validation of the Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator 17-Item Symptom Index (FACT-ICM-17) to facilitate implementation in research and clinical care

IF 5.1 2区医学 Q1 ONCOLOGY

Cancer Pub Date : 2025-10-04 DOI:10.1002/cncr.70102

Lisa M. Gudenkauf PhD, MPH, Danielle B. Tometich PhD, Aasha I. Hoogland PhD, Xiaoyin Li PhD, Kedar Kirtane MD, Brent J. Small PhD, Anna Barata PhD, Brian D. Gonzalez PhD, K. D. Jacobs PhD, Christine H. Chung MD, Michael R. Shafique MD, Jhanelle Gray MD, Nikhil I. Khushalani MD, Michael A. Postow MD, David Cella PhD, Kimberly A. Webster MA, Adam P. Dicker MD, PhD, Heather S. L. Jim PhD

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Abstract

Background

Immune checkpoint modulators (ICMs) have revolutionized cancer treatment but have unique immune-related adverse events (irAEs). The aim of this study was to develop and validate a brief measure of the most common, distressing, and diagnostically useful symptomatic irAEs.

Methods

Items were generated to assess symptomatic irAEs through a multistep process of (1) literature review and iterative expert input and (2) qualitative interviews of patients, caregivers, and clinicians regarding ICM-related irAEs and quality of life (QOL) impacts. An initial item set was administered across five longitudinal or cross-sectional studies. The final item set was selected using a Delphi method; validity, reliability, minimally important differences (MIDs), and sensitivity to change were evaluated.

Results

Qualitative interviews with 14 patients, seven caregivers, and six clinicians informed an initial set of 46 symptomatic irAEs, which was administered to patients (N = 503, 52% female, mean age = 64) treated with ICMs for non–small cell lung cancer (n = 342), head and neck cancer (n = 72), renal cell carcinoma (n = 43), or melanoma (n = 46). A final item set was selected and mapped to FACIT library items. This produced the 17-item FACT-ICM Symptom Index, which showed reliability (α = 0.86), construct validity (comparative fit index = 0.93), convergent validity with validated measures of physical QOL (r = 0.69–0.73), discriminant validity with emotional and social QOL (r = 0.03–0.65), and criterion validity (i.e., better performance status was associated with fewer concerns). Response option anchors adequately captured MIDs and were sensitive to change.

Conclusions

This brief 17-item FACT-ICM Symptom Index demonstrates initial construct, convergent, and divergent validity, reliability, MID, and sensitivity to change and is ready for use in research and clinical care.

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验证癌症治疗功能评估-免疫检查点调节剂17项症状指数（FACT-ICM-17），以促进研究和临床护理的实施

免疫检查点调节剂（ICMs）已经彻底改变了癌症治疗，但具有独特的免疫相关不良事件（irAEs）。本研究的目的是开发和验证最常见、最痛苦和诊断有用的症状性irae的简短测量方法。方法通过(1)文献回顾和反复的专家输入，(2)对患者、护理人员和临床医生就icm相关的irae和生活质量（QOL）影响进行定性访谈，生成评估症状性irae的项目。最初的项目集通过五项纵向或横断面研究进行管理。采用德尔菲法选择最终项目集；评估效度、信度、最小重要差异（MIDs）和对变化的敏感性。结果对14名患者、7名护理人员和6名临床医生进行了定性访谈，得出了46组有症状的irae，这些irae被用于接受ICMs治疗的非小细胞肺癌（N = 342）、头颈癌（N = 72）、肾细胞癌（N = 43）或黑色素瘤（N = 46）的患者（N = 503, 52%为女性，平均年龄= 64）。最终的项集被选择并映射到FACIT库项。这产生了17项的事实- icm症状指数，其信度（α = 0.86），结构效度（比较拟合指数= 0.93），与身体生活质量的验证测量的收敛效度（r = 0.69-0.73），与情绪和社会生活质量的判别效度（r = 0.03-0.65），以及标准效度（即，更好的表现状态与较少的担忧相关）。响应选项锚定了充分捕获的mid，并且对变化敏感。这个简短的17项FACT-ICM症状指数显示了初始结构、收敛和发散的效度、信度、MID和对变化的敏感性，可以用于研究和临床护理。

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