Clinical trial · Observational
Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41
SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]
NCT07504913CI-TRIAL-00106999SPQUSS-41recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
| Validation Study | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Development Questionnaire and Validation Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Development questionaire group and Validation questionaire group
- description
- 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.
- interventionNames
- Other: Development Questionnaire and Validation Questionnaire
Primary outcomes (1)
- measure
- Spanish validation of KOQUSS-40 questionnaire
- timeFrame
- At baseline and after 30 days.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDEom 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. PMID 33421981