P1683: the eortc qlq-hl27: eortc prospective international validation of a disease-specific questionnaire for assessment of health-related quality of life in patients with hodgkin lymphoma

Topic: 35. Quality of life and palliative care Background: Hodgkin lymphoma (HL) has become one of the most curable cancers. Current treatment is therefore aimed to balance cure rates and the risk of adverse events and late effects of treatment. Therefore, rigorous assessment of health-related quality of life (HRQoL) and symptom burden of these patients is essential to support informed clinical decisions. Aims: This study reports the final results of an international study by the European Organisation for Research and Treatment of Cancer (EORTC) to develop a HRQoL disease-specific measure for these patients: the EORTC QLQ-HL27. Methods: Patients with a confirmed diagnosis of HL (N=381) were enrolled from 12 countries and completed the EORTC QLQ-C30, QLQ-HL27 and a debriefing questionnaire at baseline. A subset completed a retest (N=126) or responsiveness to change analyses (RCA) second measurement (N=98). This study was performed according to the EORTC QLG guidelines for module development. In brief, this module development process consists of four phases: Phase I: generation of relevant quality of life issues; Phase II: conversion of the quality of life issues into a set of items; Phase III: pre-testing the item list or preliminary module questionnaire; and Phase IV: large-scale international field-testing. This study presents the Phase IV results. Results: Confirmatory factor analysis showed an acceptable fit of the 27 items of the QLQ-HL27 on its four scales (symptom burden, physical condition/fatigue, emotional impact, and worries about health/functioning). Test-retest reliability, convergent validity, known-group comparisons, and RCA were shown, for all or several scales. Symptom burden and fatigue was higher among patients on treatment (with 36-83% reporting at least a little problems) compared to those after treatment (19-61% reporting at least a little problems). Prevalence of items related to worry about health and functioning was similar for patients on treatment (with 51-81% reporting at least a little worry) versus after treatment (with 52-78% reporting at least a little worry). Summary/Conclusion: This large-scale international study supports the validity and clinical utility of a newly developed patient reported outcome (PRO) measure for patients with HL. The use of this disease-specific questionnaire (EORTC QLQ-HL27), in conjunction with the EORTC QLQ-C30, makes it feasible to assess most relevant symptoms and functional health issues of patients with HL. Implementation of the EORTC QLQ-HL27 in future research and clinical applications will increase sensitivity of HRQoL assessment in patients with HL. High quality data generated through use of this questionnaire are expected to facilitate clinical decision making in the HL setting. Keywords: Hodgkin’s lymphoma, Fatigue, Quality of life