ArticleCancer2025
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.
Article in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Patient-reported quality-of-life outcomes in immune checkpoint inhibitor therapy: addressing gaps, capturing patient experience, and advancing the field.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
backgroundImmune 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.
methodsItems 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.
resultsQualitative 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.
conclusionsThis 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.