Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41 (SPQUSS-41)

March 26, 2026 updated by: Anna Casajoana Badia, Parc de Salut Mar

SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]

The main objective of this study is the translation, linguistic adaptation into Spanish, and validation of the Korean quality of life questionnaire KOQUSS-40. This tool will allow us to objectively measure the quality of life of patients in clinical trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Gastric cancer treatment often involves radical surgery, significantly impacting patients' quality of life (QoL), with symptoms ranging from gastrointestinal issues to emotional distress. Existing QoL questionnaires do not comprehensively address symptoms specific to gastric surgery.

Objective:

This study aims to translate, culturally adapt, and validate the KOQUSS-40 questionnaire into Spanish (SPQUSS-41), providing a specific tool to assess QoL in patients undergoing curative gastric cancer surgery. This will enhance personalized care, patient-clinician communication, and symptom management.

Design:

A prospective, multicenter cohort study under Spain's EURECCA Esophagogastric Cancer Project. The English version of KOQUSS-40 will serve as the basis for translation. The study will unfold in two phases:

Phase 1 - Development:

Translation to Spanish and expert panel review to create version 1.

Pre-test with 20 patients for comprehension.

Pilot test with 85 patients to refine and evaluate version 2.

Phase 2 - Validation:

Administration of the final version alongside EORTC QLQ-C30 and QLQ-STO22.

A retest will be conducted after 30 days to assess test-retest reliability.

Study Population:

Adults (>18 years) who underwent curative gastric cancer surgery, from 1 month to 5 years post-op.

Inclusion criteria: Surgery with curative intent, consent to EURECCA and SPQUSS-41 studies.

Exclusion criteria: Other malignancies, advanced/metastatic disease, palliative surgery, or prior QoL questionnaires related to gastric cancer.

Data Collection:

Demographic and clinical-pathological data will be collected, including surgery type, lymphadenectomy, pathological stage, and oncologic treatment. Data will be recorded in the EURECCA online registry using a 6-digit patient code.

Sample Size:

Following the "rule of 10," at least 410 patients are required (10 patients per item, 41 items). A test-retest sample of 381 patients is planned, with expected participation from at least 10 centers over 1-2 years.

Statistical Analysis:

Descriptive statistics for demographic/clinical variables.

Construct validity via principal component analysis.

Criterion validity using Pearson correlations and EORTC questionnaires.

Internal consistency via Cronbach's alpha.

Test-retest reliability via Spearman correlation and Cohen's weighted kappa.

Analysis in SPSS 28.0; significance at p < 0.05.

Work Plan - Six Work Packages:

WP1: Study protocol, ethics approval, trial registration, and database setup.

WP2: Initial translation and expert consensus (Version 1).

WP3: Pre-test with 20 patients and refinement (Version 2).

WP4: Pilot test with 85 patients using Version 2 and reference tools. Final expert review to establish the final version.

WP5: Launch validation phase across centers. Administer final questionnaire to 410 patients and conduct retest with 381.

WP6: Data analysis, manuscript preparation, and dissemination of validated SPQUSS-41 questionnaire in Spanish.

Study Type

Observational

Enrollment (Estimated)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Active, not recruiting
        • Hospital Universitario de Bellvitge
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Recruiting
        • Hospital Universitario Puerto Real
        • Contact:
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Recruiting
        • Hospital Universitario San Pedro
        • Contact:
    • Lleida
      • Lleida, Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitario Arnau de Vilanova
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study patients will come from the centers that are currently part of the Spanish EURECCA Group for Esophagogastric Cancer (GEECEG) in Spain. The GEECEG was created in 2013 and collects prospective and validated information from all patients operated on for esophagogastric cancer in public hospitals of 8 Autonomous Communities. The registry records 116 variables that cover all the care stages of monitoring and treatment of patients with gastric cancer.

Description

Inclusion Criteria:

  • Patients operated on for gastric cancer with curative intent from 1 month postoperatively up to the last 5 years
  • Adult patients over 18 years old
  • No recurrence of the disease
  • Patients who have given their informed consent to participate in the Spanish EURECCA Registry of Esophagogastric Cancer and have signed the specific consent for the SPQUSS-4 study

Exclusion Criteria:

  • First 30 days after surgery and/or patients with postoperative complications requiring more than 30 days of hospitalization.
  • Patients who do not give their consent to participate in the study will be excluded.
  • Patients with a history of other neoplasms.
  • Patients with disseminated gastric cancer or candidates for palliative surgery, as well as those patients who do not give their consent to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Development questionaire group and Validation questionaire group

Eligible participants will be patients who meet the inclusion criteria outlined above, namely: adults aged 18 years or older who have undergone gastric cancer surgery with curative intent, from 1 month postoperatively up to 5 years of follow-up, and who have provided informed consent to participate in the Spanish EURECCA Registry for Esophagogastric Cancer as well as signed the specific informed consent for the SPQUSS-4 study.

Exclusion criteria for both the development and validation phases will include patients who do not provide informed consent; those with a history of other malignancies; patients with disseminated gastric cancer or candidates for palliative surgery; and patients who have previously completed any quality-of-life questionnaire related to the diagnosis or treatment of gastric cancer.
Other: Development Questionnaire and Validation Questionnaire
The intervention consists of administering the questionnaires at the different phases of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spanish validation of KOQUSS-40 questionnaire
Time Frame: At baseline and after 30 days.
The main objective of this study is the translation and linguistic adaptation into Spanish, as well as the validation, of the Korean quality-of-life questionnaire KOQUSS-40, originally developed in the Korean setting (SPQUSS, SPanish QUality of life in Stomach cancer patients Study group). This tool will allow us to objectively measure patients' quality of life in clinical trials.
At baseline and after 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Hospital del Mar Research Institute (IMIM)
Asociación Española de Cirugía

Investigators

  • Study Director: Manuel Pera, PhD, Hospital del Mar de Barcelona
  • Principal Investigator: Anna Casajoana, Hospital del Mar de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/11553/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to data protection regulations (e.g., GDPR) and because the informed consent obtained from participants does not include provisions for data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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