Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorParc de Salut Mar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Development Questionnaire and Validation Questionnaire
Other interventionThe intervention consists of administering the questionnaires at the different phases of the study.
Treatment groups
505 Participants
are divided into 1 treatment groupGroup A: Development questionaire group and Validation questionaire group1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Parc de Salut Mar
Lead sponsor
Hospital del Mar Research Institute (IMIM)
Collaborator
Asociación Española de Cirugía
Collaborator
Source ClinicalTrials.gov