Clinical trial NCT02853422: Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours
Official title: A Study Evaluating The Clinical Utility Of The Health-Related Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours QUALINETS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients

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


Eligibility criteria: 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).

Primary outcomes:
measure: Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled
timeFrame: Day 1
Secondary outcomes:
measure: Socio-demographic variables of the investigator
timeFrame: Day 1
measure: Socio-demographic variables of the patient
timeFrame: Day 1
measure: Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21
timeFrame: Day 1
measure: Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30
timeFrame: Day 1
measure: Clinical characteristics of patients - time since first therapeutic intervention
timeFrame: Day 1
measure: Health status as perceived by the patient
timeFrame: Day 1
measure: Clinical assessment of patient's health status by the investigator
timeFrame: Day 1
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto Portuguès de Oncologia de Lisboa
city: Porto
country: Portugal
facility: Instituto Portuguès de Oncologia do Porto
city: Alicante
country: Spain
facility: Hospital General Univ. Elche
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial
city: Burgos
country: Spain
facility: Hospital Univ. Burgos
city: Ciudad Real
country: Spain
facility: Hospital General Univ. Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Jerez de la Frontera
city: Gijón
country: Spain
facility: Hospital Univ. de Cabueñes
city: Girona
country: Spain
facility: ICO Girona
city: Ibiza
country: Spain
facility: Hospital Can Mises
city: León
country: Spain
facility: Hospital Univ. León
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Univ. Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Univ. Puerta del Hierro
city: Malaga
country: Spain
facility: Hospital Univ.Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital General Univ. Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Regional Univ. Málaga
city: Móstoles
country: Spain
facility: Hospital Rey Juan Carlos I
city: Palma
country: Spain
facility: Hospital Univ. Son Espases
city: Palma
country: Spain
facility: Hospital Son Llàtzer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: Hospital Clínico Univ. Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Univ. de Santiago
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Univ. Virgen del Rocío
city: Terrassa
country: Spain
facility: Hospital Univ. Mútua de Terrasa
city: Usansolo
country: Spain
facility: Hospital de Galdakao
city: Valencia
country: Spain
facility: Hospital Univ. Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Univ. Valladolid
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: