An observational study in Stomach Neoplasms and Validation Study, sponsored by Parc de Salut Mar. Recruiting at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Parc de Salut Mar · Observational
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 505 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Spanish validation of KOQUSS-40 questionnaire
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.
Time frame: At baseline and after 30 days.
Not enrolling at this site.
Plan to share: No — 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.
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