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.

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 chan

SUBMITTER: Gudenkauf LM 

PROVIDER: S-EPMC12741858 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature