Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours

Completed

• Conditions: Gastrointestinal Neuroendocrine Tumours

• Registration Number: NCT02853422
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Patient with a diagnosis of gastrointestinal endocrine tumour.
• Patient able to read and understand the study questionnaires.
• Patient who has given informed consent in writing to take part in the study.

Exclusion Criteria

• Patient who is taking part in another clinical study during the study.
• Patients with another serious malignancy.
• Patients unable to meet the requirements of the protocol (non-compliant patients or those unfit to answer the questionnaires).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled	Day 1

Secondary Outcome Measures

Name	Time	Method
Socio-demographic variables of the investigator	Day 1	Descriptive analysis of socio-demographic variables including age, gender, years of experience in treating neuroendocrine tumours (NETs), area of professional activity, capacity of the hospital
Socio-demographic variables of the patient	Day 1	Descriptive analysis of socio-demographic variables including age, gender, employment status, marital status, educational level
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21	Day 1
Health status as perceived by the patient	Day 1	Patients assess their overall health status in relation to their gastrointestinal neuroendocrine tumour, with a question designed for this purpose: "Please answer the question by marking the response that best defines your current health status as related to your neuroendocrine disease". The response options are: Very good, quite good, somewhat good, neither good nor bad, somewhat bad, quite bad, very bad.
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30	Day 1
Clinical assessment of patient's health status by the investigator	Day 1	The investigator evaluates the patient's health status in relation to the gastrointestinal neuroendocrine tumour by answering the following question: Overall, how would you rate the patient's health status in relation to their gastrointestinal neuroendocrine tumour as of today? The response options are: Very good, quite good, somewhat good, neither good nor bad, somewhat bad, quite bad, very bad.
Clinical characteristics of patients - time since first therapeutic intervention	Day 1

Trial Locations

Locations (32)

Hospital de La Princesa; 🇪🇸 Madrid, Spain

ICO Girona; 🇪🇸 Girona, Spain

Hospital General Univ. Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital General Univ. Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Univ. Puerta del Hierro; 🇪🇸 Madrid, Spain

Hospital Clínico Univ. de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Univ.Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Univ. Son Espases; 🇪🇸 Palma, Spain

Hospital Univ. Mútua de Terrasa; 🇪🇸 Terrassa, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital de Galdakao; 🇪🇸 Usansolo, Spain

Instituto Portuguès de Oncologia do Porto; 🇵🇹 Porto, Portugal

Hospital Univ. de Cabueñes; 🇪🇸 Gijón, Spain

Hospital Clinico y Provincial; 🇪🇸 Barcelona, Spain

Hospital Univ. Burgos; 🇪🇸 Burgos, Spain

Hospital Jerez de la Frontera; 🇪🇸 Cádiz, Spain

Instituto Portuguès de Oncologia de Lisboa; 🇵🇹 Lisboa, Portugal

Hospital Son Llàtzer; 🇪🇸 Palma, Spain

Hospital Univ. Fe; 🇪🇸 Valencia, Spain

Hospital Univ. León; 🇪🇸 León, Spain

Hospital Univ. Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Regional Univ. Málaga; 🇪🇸 Málaga, Spain

Hospital Clínico Univ. Salamanca; 🇪🇸 Salamanca, Spain

Hospital General de Segovia; 🇪🇸 Segovia, Spain

Hospital Rey Juan Carlos I; 🇪🇸 Móstoles, Spain

Hospital Univ. Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clínico Univ. Valladolid; 🇪🇸 Valladolid, Spain

Hospital Can Mises; 🇪🇸 Ibiza, Spain

Hospital General Univ. Elche; 🇪🇸 Alicante, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain