Update of the EORTC Quality of Life Gastric Module

• Research type

  Research Study

• Full title

  Phase I-II of the update of the EORTC Quality of Life Gastric module QLQ-STO22.

• IRAS ID

  278916

• Contact name

  Samantha Sodergren

• Contact email

  S.C.Sodergren@soton.ac.uk

• Sponsor organisation

  University of Southampton

• Duration of Study in the UK

  1 years, 3 months, 29 days

• Research summary

  The EORTC QLQ-STO22 (STO22) has been used internationally as a measure of the specific health-related quality of life (HRQoL) concerns of patients with gastric cancer (GC). The GC-specific module was developed in 2001 and although it one of the most well-established instruments for measuring the QOL of GC patients, there are some points worth considering which suggest a need to revisit the module and identify necessary modifications. Firstly, treatment strategy and drugs for systemic therapy have dramatically changed since the module was developed.
  The original STO22 measurement tool might not sufficiently cover the specific side-effects (such as skin rashes, peripheral neuropathy, mucositis) of these new and current regimens, which involve more intense and toxic chemotherapeutic agents Additionally, the surgical procedure for GC has shifted to a less invasive approach and thus the current version of the STO22 might not adequately cover post-surgical complications. An additional consideration relates to the absence of any contribution of specialists and patients from East Asian countries (Japan, Korea, China, Taiwan and Mongolia) in the development of the STO22. This is particularly important given that patient characteristics and treatment strategies are likely to be different in East Asian countries compared to Europe. The study will recruit 90 patients with GC and 15 HCPs across Europe and East Asia. Participants will be interviewed about their experiences of GC and asked to evaluate the current STO22. Study objectives include: 1) Assess the need for an updated STO22 questionnaire to accommodate changes to treatment modalities and include the perspective of patients and clinicians from East Asia; 2) Develop a provisional draft updated STO22 covering new treatment schedules and the experiences of patients with GC from East Asia thus positioning the STO22 more globally as a standard module to assess HRQOL of GC patients.
  

• REC name

  London - Brent Research Ethics Committee

• REC reference

  20/PR/0146

• Date of REC Opinion

  7 Jul 2020

• REC opinion

  Favourable Opinion