Spanish SPQUSS-41 questionnaire to measure quality of life after stomach cancer surgery
SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]
We will test whether the Spanish SPQUSS-41 questionnaire accurately measures quality of life in adults who had curative stomach cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 505 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 6 sites (Badalona, Barcelona and 5 other locations) |
| Trial ID | NCT07504913 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter Spanish project to translate, culturally adapt, and validate the KOQUSS-40 into Spanish (SPQUSS-41). The process includes expert panel review, pre-testing with 20 patients, a pilot with about 85 patients, and a larger validation phase where SPQUSS-41 is administered alongside EORTC QLQ-C30 and QLQ-STO22. A 30-day retest will measure test–retest reliability and psychometric properties will be analyzed across participants enrolled from participating hospitals. The aim is to produce a reliable Spanish questionnaire specific to symptoms and quality-of-life issues after gastrectomy.
Who should consider this trial
Good fit: Adults over 18 who underwent curative-intent gastrectomy 1 month to 5 years ago, have no recurrence, and can provide informed consent are the intended participants.
Not a fit: Patients within the first 30 days post-op, those with metastatic or other active malignancies, or those unable/unwilling to consent are not expected to benefit from this validation effort.
Why it matters
Potential benefit: If successful, SPQUSS-41 will give Spanish-speaking clinicians and researchers a validated, surgery-specific tool to better track symptoms and guide post-gastrectomy care and communication.
How similar studies have performed: Related KOQUSS instruments have been used and translated in other settings with acceptable psychometric results, but the SPQUSS-41 is a new Spanish adaptation undergoing formal validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Badalona, Barcelona and 5 other locations
- Hospital Universitario Germans Trias y Pujol — Badalona, Barcelona, Spain (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Active_not_recruiting)
- Hospital Universitario Puerto Real — Puerto Real, Cadiz, Spain (Recruiting)
- Hospital Universitario San Pedro — Logroño, La Rioja, Spain (Recruiting)
- Hospital Universitario Arnau de Vilanova — Lleida, Lleida, Spain (Recruiting)
Study contacts
- Principal investigator: Anna Casajoana — Hospital del Mar de Barcelona
- Study coordinator: Marta Gimeno, Data Manager
- Email: eurecca.geeceg@gmail.com
- Phone: +34676078897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.