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Background <p>Cutaneous T-cell lymphomas (CTCLs) are a heterogeneous group of non-Hodgkin lymphomas characterized by neoplastic T cells in the skin. Common subtypes of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS). Patients with MF/SS can experience significant symptoms that affect health-related quality of life (HRQoL). Although the Functional Assessment of Cancer Therapy–Cutaneous T-Cell Lymphoma (FACT-CTCL) was developed as a disease-specific patient-reported outcome measure (PROM) for MF/SS, qualitative evaluation of its content validity in the target population has not been assessed. We therefore evaluated the content validity of the FACT-CTCL in patients with MF/SS and clinicians with expertise in MF/SS.</p> Methods <p>Semi-structured cognitive interviews of patients with a diagnosis of MF or SS, as well as healthcare providers with expertise in treating MF/SS were conducted in alignment with the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). Patients evaluated the relevance, comprehensibility, and comprehensiveness of the FACT-CTCL. Clinicians evaluated relevance and comprehensiveness.</p> Results <p>Twelve patients (9 MF, 3 SS) and eight clinician experts (3 oncologists, 4 dermatologists, 1 nurse practitioner) participated. The median age of patients was 68 years (range 36–77); six had early-stage (IA – IIA) disease and six had advanced-stage (IIB – IVB) disease. All items were deemed relevant by at least 95% of participants, and 44 of 47 items achieved 100% relevance across patients and clinicians. All items achieved at least 90% comprehensibility among patients, and 39 of 47 scored items were understood by all patients. All patients found the instructions and response options easy to understand, and all participants considered the instrument comprehensive.</p> Conclusions <p>The FACT-CTCL demonstrated strong content validity in this sample of patients with MF/SS and expert clinicians. These findings support further evaluation and use of the FACT-CTCL as a disease-specific HRQoL instrument in MF/SS, while additional study in larger and more diverse populations remains warranted.</p>

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Assessing content validity of the functional assessment of cancer therapy–cutaneous T-cell lymphoma (FACT-CTCL): a qualitative study

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  • 发表日期：

    2026年6月23日

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  • Caroline Raymundo,
  • Jenny Jung Sun Park,
  • Mengyang Di,
  • Cecilia Larocca,
  • David Cella,
  • Michi M Shinohara

摘要

Background

Cutaneous T-cell lymphomas (CTCLs) are a heterogeneous group of non-Hodgkin lymphomas characterized by neoplastic T cells in the skin. Common subtypes of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS). Patients with MF/SS can experience significant symptoms that affect health-related quality of life (HRQoL). Although the Functional Assessment of Cancer Therapy–Cutaneous T-Cell Lymphoma (FACT-CTCL) was developed as a disease-specific patient-reported outcome measure (PROM) for MF/SS, qualitative evaluation of its content validity in the target population has not been assessed. We therefore evaluated the content validity of the FACT-CTCL in patients with MF/SS and clinicians with expertise in MF/SS.

Methods

Semi-structured cognitive interviews of patients with a diagnosis of MF or SS, as well as healthcare providers with expertise in treating MF/SS were conducted in alignment with the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). Patients evaluated the relevance, comprehensibility, and comprehensiveness of the FACT-CTCL. Clinicians evaluated relevance and comprehensiveness.

Results

Twelve patients (9 MF, 3 SS) and eight clinician experts (3 oncologists, 4 dermatologists, 1 nurse practitioner) participated. The median age of patients was 68 years (range 36–77); six had early-stage (IA – IIA) disease and six had advanced-stage (IIB – IVB) disease. All items were deemed relevant by at least 95% of participants, and 44 of 47 items achieved 100% relevance across patients and clinicians. All items achieved at least 90% comprehensibility among patients, and 39 of 47 scored items were understood by all patients. All patients found the instructions and response options easy to understand, and all participants considered the instrument comprehensive.

Conclusions

The FACT-CTCL demonstrated strong content validity in this sample of patients with MF/SS and expert clinicians. These findings support further evaluation and use of the FACT-CTCL as a disease-specific HRQoL instrument in MF/SS, while additional study in larger and more diverse populations remains warranted.