Journal Article

Protocol for a mixed-methods modified Delphi study for the development of a core domain set to assess the health-related quality of life of patients with mycosis fungoides and Sézary syndrome in clinical trials

Scarisbrick, Julia, Mehta Shah, Neha, Khan, Niloufer, Shinohara, Michi M, Chen, Jennifer, Perez-Chada, Lourdes, Park, Jenny, Tawa, Marianne, Kim, Ellen J, Ottevanger, Rosanne, Raymundo, Caroline, Asare, Christina, Olsen, Elise, Nayudu, Krithika, Thornton, Susan, Larocca, Cecilia

2026

Overview

IntroductionCutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.Methods and analysisMultiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.Ethics and disseminationThe study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.Registration detailsThe protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Advocacy / Caregivers / Chronic illnesses / Clinical medicine / Clinical outcomes / Clinical trials / Clinical Trials as Topic / Consensus / Consortia / Delphi method / Delphi Technique / Dermatological tumours / Dermatology / Fungal infections / Humans / Literature reviews / Lymphoma / Medical personnel / Mycosis Fungoides - psychology / Mycosis Fungoides - therapy / ONCOLOGY / Patient Reported Outcome Measures / Patient satisfaction / Professionals / Protocol / QUALITATIVE RESEARCH / Quality of Life / Research Design / Sezary Syndrome - psychology / Sezary Syndrome - therapy / Skin Neoplasms - psychology / Systematic review / Systematic Reviews as Topic / Working groups