The Evaluation of Health-Related Quality of Life Issues Experienced by Patients with Desmoid-Type Fibromatosis (The QUALIFIED Study)-A Protocol for an International Cohort Study

Anne-Rose W Schut, Milea J M Timbergen, Emma Lidington, Dirk J Grünhagen, Winette T A van der Graaf, Stefan Sleijfer, Winan J van Houdt, Johannes J Bonenkamp, Eugenie Younger, Alison Dunlop, Robin L Jones, Cornelis Verhoef, Spyridon Gennatas, Olga Husson*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Sporadic desmoid-type fibromatosis (DTF) is a rare soft tissue tumour with an unpredictable clinical course. These tumours are incapable of metastasising, but their local aggressive tumour growth and tendency to recur locally can result in a substantial symptom burden. Measuring the impact of DTF on health-related quality of life (HRQoL) can be challenging due to the variable clinical presentation of the disease. Therefore, a HRQoL instrument assessing DTF-specific issues is needed. The QUALIFIED study aims to (1) pre-test a previously developed DTF-specific HRQoL tool (the DTF-QoL); (2) evaluate prevalence of HRQoL issues in adult DTF patients; and (3) identify subgroups at risk of impaired HRQoL. This study (NCT04289077) is an international, multicentre, cross-sectional, observational cohort study. Patients ≥ 18 years with sporadic DTF from the Netherlands and the United Kingdom will be invited to complete a set of questionnaires specifically composed for this patient group. Questionnaires will be completed using PROFILES (Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship). Analyses will include testing the psychometric properties of the DTF-QoL and evaluating the prevalence of HRQoL issues using the DTF-QoL, EORTC QOL-C30 and EQ-5D-5L, among other questionnaires. This study will provide insight into HRQoL issues experienced by patients with DTF. Awareness of these issues and the implementation of the DTF-QoL in research and clinical practice can help to improve overall HRQoL and to provide personalised care.

Original languageEnglish
Article number3068
JournalCancers
Volume13
Issue number13
DOIs
Publication statusPublished - 1 Jul 2021

Bibliographical note

Funding Information:
Funding: This research was funded by Stichting Coolsingel, Rotterdam, the Netherlands (grant number 566), the National Institute for Health Research (NIHR) Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London (B038). Husson is supported by a Social Psychology Fellowship from the Dutch Cancer Society (#KUN2015-7527) and by a grant from the Netherlands Organization for Scientific Research (VIDI198.007).

Funding Information:
This research was funded by Stichting Coolsingel, Rotterdam, the Netherlands (grant number 566), the National Institute for Health Research (NIHR) Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London (B038). Husson is supported by a Social Psychology Fellowship from the Dutch Cancer Society (#KUN2015-7527) and by a grant from the Netherlands Organization for Scientific Research (VIDI198.007). R.L.J. has received research grants from MSD and GSK and is a consultant for Adaptimmune, Athenex, Bayer, Boehringer Ingelheim, Blueprint, Clinigen, Eisai, Epizyme, Daichii, Decipheara, Immunedesign, Lilly, Merck, Pharmacar, Springworks, Tracon and Upto Date. W.T.A.v.d.G. has received research grants from Novartis and Lilly, consultancy fees from Springworks and was on an advisory board for Bayer; all fees to the institute. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

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