Stomach NeoplasmsSPQUSS-41NCT07504913
Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41
An observational study of Stomach Neoplasms and Validation Study, run by Parc de Salut Mar at 6 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Validation Study
- What is being tested?
- Development Questionnaire and Validation Questionnaire
- How many people
- 505 participants
- Where
- 6 sitesSpain
- Study dates
- 3 May 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 5 recruiting
- Recruiting
Hospital Universitario Germans Trias y Pujol
Badalona, Barcelona, 08916
Elisenda Garsot, +34696251658, egarsot.germanstrias@gencat.ca
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Sandra Castro, PhD, +34 656381552, scastroboix@gmail.com
- Active, not recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Hospital Universitario Arnau de Vilanova
Lleida, Lleida, 25198
Helena Salvador, +34617565832, hsalvadorroses@gmail.com
- Recruiting
Hospital Universitario San Pedro
Logroño, La Rioja, 26006
Rafael Gil, +34609906618, rgalbarellos@gmail.com
- Recruiting
Hospital Universitario Puerto Real
Puerto Real, Cadiz, 11510
Maria Isabel Marín Herrero, +34687420437, mariauci@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stomach Neoplasms, Validation Study
- Being tested
- Development Questionnaire and Validation Questionnaire
- Keywords
- Stomach neoplasms, Validation study, Surveys and questionnaires, Quality of life
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development Questionnaire and Validation QuestionnaireOther
The intervention consists of administering the questionnaires at the different phases of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Development Questionnaire and Validation Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start3 May 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Asociación Española de Cirugía
- Responsible party
- Principal investigator, Anna Casajoana Badia, Parc de Salut Mar
- Investigators
- Manuel Pera, PhD, Study director, Hospital del Mar de BarcelonaAnna Casajoana, Principal investigator, Hospital del Mar de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504913
- Sponsor's protocol ID
- 2024/11553/I
- Acronym
- SPQUSS-41
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Eom BW, Lee J, Lee IS, Son YG, Ryu KW, Kim SG, Kim HI, Kim YW, Kong SH, Kwon OK, Park JH, An JY, Kim CH, Suh BJ, Yoon HM, Son MW, Park JY, Park JM, Jeong SH, Yoo MW, Song GJ, Yang HK, Suh YS, Park KB, Ahn SH, Shin DW, Jee YS, Ahn HS, Lee S, Min JS, In H, Kim A, Hur H, Lee HJ; KOrean QUality of life in Stomach cancer patients Study group (KOQUSS). Development and Validation of a Symptom-Focused Quality of Life Questionnaire (KOQUSS-40) for Gastric Cancer Patients after Gastrectomy. Cancer Res Treat. 2021 Jul;53(3):763-772. doi: 10.4143/crt.2020.1270. Epub 2020 Dec 29.
PubMed 33421981
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]
- ClinicalTrials.gov ID
- NCT07504913
- Acronym / sponsor ID
- SPQUSS-41 / 2024/11553/I
- Conditions
- Stomach Neoplasms, Validation Study
- Keywords
- Stomach neoplasms, Validation study, Surveys and questionnaires, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Asociación Española de Cirugía
- Study start
- 3 May 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Development questionaire group and Validation questionaire group | – | Other: Development Questionnaire and Validation QuestionnaireEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development Questionnaire and Validation QuestionnaireThe intervention consists of administering the questionnaires at the different phases of the study. | Other | Development questionaire group and Validation questionaire group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 33421981Eom BW, Lee J, Lee IS, Son YG, Ryu KW, Kim SG, Kim HI, Kim YW, Kong SH, Kwon OK, Park JH, An JY, Kim CH, Suh BJ, Yoon HM, Son MW, Park JY, Park JM, Jeong SH, Yoo MW, Song GJ, Yang HK, Suh YS, Park KB, Ahn SH, Shin DW, Jee YS, Ahn HS, Lee S, Min JS, In H, Kim A, Hur H, Lee HJ; KOrean QUality of life in Stomach cancer patients Study group (KOQUSS). Development and Validation of a Symptom-Focused Quality of Life Questionnaire (KOQUSS-40) for Gastric Cancer Patients after Gastrectomy. Cancer Res Treat. 2021 Jul;53(3):763-772. doi: 10.4143/crt.2020.1270. Epub 2020 Dec 29.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manuel Pera, PhD study director
Hospital del Mar de Barcelona
Anna Casajoana principal investigator
Hospital del Mar de Barcelona
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Validation Study, run by Parc de Salut Mar at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Gimeno, Data Manager (+34676078897, eurecca.geeceg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spanish validation of KOQUSS-40 questionnaire (time frame: At baseline and after 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.