EORTC patient reported symptomatic adverse events inventory

• Research type

  Research Study

• Full title

  Development of the Cancer Patient-reported Symptomatic Adverse Events Inventory (EORTC-PROAE) Using the EORTC Item Library: qualitative interview study

• IRAS ID

  346596

• Contact name

  Alexandra Gilbert

• Contact email

  a.gilbert@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  1 years, 4 months, 25 days

• Research summary

  The European Organisation of Research and Treatment of Cancer’s Quality of Life Group (EORTC QLG) has developed a four-phase framework that can be used to develop and validate quality of life questionnaires for individuals with cancer. These are developed as modules to supplement their existing EORTC core quality of life questionnaire, the ‘QLQ-C30’. The four-phase approach comprises a literature review followed by interviews with patients and clinicians (Phase 1), construction of a questionnaire (Phase 2), refinement of the questionnaire (Phase 3a - content validity; Phase 3b - initial psychometrics), and finally administration of the questionnaire to an international sample in a full validation study (Phase 4).
  Previous work summarised all 950 items (questions) included in all 67 questionnaires developed by QLG and included in the EORTC Item Library. The results of this work showed that nine symptomatic adverse events (AEs) were not included in these questionnaires and recommended development of items (questions) to measure them.
  The present study aims develop 9 questions to include in the EORTC Library designed to measure nine cancer AEs which are currently missing from the existing questionnaires: hiccups, wheezing, acne, stretch marks, ringing in ears, missed expected menstrual period, change in usual urine colour, decreased sweating, and body odour. The study aims to undertake phase 3a of the above module development process which involves interviews with patients to ensure the content validity of the items developed.

  In addition, we aim to ascribe an individual question from the EORTC Item Library to each symptomatic adverse event. For some adverse events, there are multiple question options available. We will also ask patients in these interviews to help us decide on the best question to select.
  

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  24/NW/0367

• Date of REC Opinion

  28 Nov 2024

• REC opinion

  Favourable Opinion