Gastric Cancer (update of QLQ-STO22)

The EORTC QLQ-STO22 (QLQ-STO22) is one of the most used measures of quality of life (QoL) for people with stomach (gastric) cancer (GC). We are updating the QLQ-STO22 to capture issues related to new and diverse treatment approaches which have been developed since development of the original QLQ-STO22 in 2001. The update will also include perspectives of patients and healthcare professionals (HCPs) from East Asia, who were not included in the original development of the QLQ-STO22.

Following the Phase 1 systematic review and interviews with HCPs and patients, items covering eating small amounts, neuropathy and flatulence (n=5) were added. In Phase 2, the EORTC QoL group (QLG) and translation team recommended removing items which covered thinking about illness and worry about future health (n=2) and making linguistic changes to some items (n=7). Therefore, the QLQ-STO22 update preliminary item list covers 25 items.

We are currently in Phase 3 which involves pilot testing the updated version of the questionnaire with a larger group of patients with GC (n=175-250) including those from East Asia. The aim will be to 1) identify and solve potential problems in its administration and provide further opportunity to identify any confusing, unacceptable, missing or redundant issues; 2) carry out a preliminary evaluation of the psychometric properties of the updated QLQ-STO22, and explore the content and structure of the updated draft measure; 3) further examine any cultural differences in the QoL experiences of patients from East Asia and non-East Asia.

Phase 4 will include a full-scale international validation of the final GC module, involving a large sample (i.e. >400).

Compiling an impressive list of enthusiastic and engaged collaborators from East Asia and non-East Asia

Current status:

Phase 3 protocol writing and ethical approval application.

Phase 3a

Feb-Mar 2026 (1-2 months)

Study paperwork: Protocol, Participant facing documents and other study-related documents needed to efficiently run the study

Feb-Jun 2026 (1-5 months)

Research Governance and Ethics at lead site (Sponsor and National Ethics)

May-Aug 2026 (4-7 months)

Set-up of all collaborating sites, applications for ethical approvals, data sharing agreements.

Jul 2026-Mar 2027 (6-14 months)

Data collection (N=75-80)

Apr-Jun 2027 (15-17 months)

Phase 3a analyses and report to the PMDC

Phase 3b

Jul-Aug 2027 (18-19 months)

Phase 3b preparation of any updates to the QLQ-STO22 (i.e., additional items, re-worded questions) and necessary ethics amendments

Sep 2027-Oct 2028 (20-33 months)

Phase 3b data collection (N=175-200)

Oct 2028-Apr 2029 (33-39 months)

Phase 3b analyses (descriptive and exploratory psychometric analyses). Working in partnership with the PMDC and Translation Unit to implement any necessary changes.

May 2029 (40 months)

Submission of the Phase 3 report and publication on behalf and for approval by the EORTC QLG

The EORTC QLQ-STO22 (QLQ-STO22), developed in 2001, is one of the most used quality of life (QoL) questionnaires for people with stomach (gastric) cancer (GC). We are updating it to cover new treatments for GC, and the views of patients and healthcare professionals (HCPs) from East Asia who were not included in the original development.

After a systematic review of the literature and interviews with HCPs and patients, five questions covering eating small amounts, neuropathy and flatulence were added. The EORTC QoL Group and translation team also removed two questions on thinking about illness and worry about future health, and revised seven questions. Therefore, the QLQ-STO22 updated version has 25 questions.

We are going to pilot test this updated version on 175-250 patients, including those from East Asia, to identify any problems or issues; check its trustworthiness and accuracy; examine any cultural differences in the QoL experiences of patients from East Asia and non-East Asia.