Gastric Cancer (update of QLQ-STO22)

Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Mitsumi Terada
Principal Investigator
National Cancer Centre, Tokyo
Tokyo, Japan
, Vassilios Vassiliou
Principal Investigator
Bank of Cyprus Oncology Centre
Limassol, Cyprus
, Samantha Sodergren
Principal Investigator
Faculty of Health Sciences, University of Southampton
Southampton, United Kingdom
Study coordinator(s)
Alison Rowsell
Principal Investigator
University of Southampton
Southampton, United Kingdom

Project summary

Although the EORTC QLQ-STO22 is one of the most well-established instruments for measuring the HRQOL of people with gastric cancer, the module is in need of a potential update in order to capture the Health related quality of life (HRQoL) issues related to the new and diverse treatment strategies which have emerged since the development of the original QLQ-STO22 and to include the perspective of patients and health care professionals from East Asia.
This study is conducted within the network of the EORTC QLG, EORTC Gastrointestinal Tract Cancer Group, and the Japan Clinical Oncology Group (JCOG) Stomach Cancer Study Group including different countries of the European Union, UK, China, Mongolia, South Korea and Japan.
1.1.1 The update of the QLQ-STO22 project has two overall objectives:
1) Evaluate the need for an updated QLQ-STO22 to accommodate changes to treatment modalities and to include the perspective of patients and clinicians from East Asia.
2) To 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.

In order to identify the HRQOL issues of importance and relevance to people with gastric cancer globally (including East Asia), we will be reviewing the literature and asking patients and health care professionals to share their experiences and opinions. During the first phase, we will invite 60 people with stomach cancer, to comment on the existing QLQ-STO22 to see if the questions are relevant to them and whether anything has been overlooked. We are interested in finding out about all the different ways the effects of stomach cancer and its treatment affect people’s lives. The research will explore the best way to measure the effects of stomach cancer on people’s lives and look at whether the current questionnaire (QLQ-STO22) is suitable. We want to be sure we are capturing issues from people in different countries. We especially want to understand the issues for people in East Asia where people’s experiences have been under reported. After we have carried out our first set of interviews across different centres and countries, we will be in a position to propose any changes to the questionnaire which will subsequently be reviewed for relevance by an additional 30 patients and 15 healthcare professionals.

Achievements

• A systematic Review: Review of Health Related Quality of Life (HRQoL) issues related to Gastric Cancer: Capturing cross-cultural differences. This manuscript has been prepared pending submission in Autumn 2021.
• Ethical permissions have been granted at all sites.
• Active collaboration with sites to initiate set-up has been completed.
• 8 sites (UK, Japan (2 centres), Spain, Cyprus, Mongolia, Malaysia and Turkey) took part in Phase 1a and 61 interviews with patients were completed. Phase 1a has been completed (May 2021)
• 10 sites are currently taking part in Phase 1b data collection, reviewing the new issue list (UK-3 centres), Japan (2 centres), Turkey, Spain, India, Malaysia, Mongolia, South Korea, China and Norway).
• The update questionnaire will be reviewed by patients and healthcare professionals in January-March 2021.

Current status:

  • Phase 1a is now closed to recruitment.
  • Phase 1b opened to recruitment in June 2021 and will close at the end of September 2021.

For patients

We are conducting a study which asks adults with stomach cancer to look at a questionnaire to see if the questions and issues are relevant to them. This will help us find out about all the different ways stomach cancer and its treatment affect people’s lives. We want to find the best way to measure the effects of stomach cancer on people’s lives and whether a current questionnaire we have is suitable. We are showing people with stomach cancer a questionnaire which has been developed for people like them and will interview them about the questionnaire. We are interested in their thoughts on the issues in the questionnaire and also on whether they have any suggestions for questions or have experienced any other issues not covered by the questionnaire. We are particularly interested in whether the issues are the same for people in different parts of the world, including East Asia. Therefore, we will be talking to people from many countries. Once we have spoken to people with gastric cancer and reviewed the questionnaire and issues with patients and healthcare professionals, we will update the questionnaire if it needs it.