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

November 4, 2020 updated by: Ipsen

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto
  • Spain
      • Alicante, Spain, 03203
        • Hospital General Univ. Elche
      • Barcelona, Spain, 08036
        • Hospital Clinico Y Provincial
      • Burgos, Spain, 09006
        • Hospital Univ. Burgos
      • Ciudad Real, Spain, 13005
        • Hospital General Univ. Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Cádiz, Spain, 11407
        • Hospital Jerez de la Frontera
      • Gijón, Spain, 33394
        • Hospital Univ. de Cabueñes
      • Girona, Spain, 17007
        • ICO Girona
      • Ibiza, Spain, 07800
        • Hospital Can Mises
      • León, Spain, 24001
        • Hospital Univ. León
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28034
        • Hospital Univ. Ramón y Cajal
      • Madrid, Spain, 28222
        • Hospital Univ. Puerta del Hierro
      • Malaga, Spain, 29010
        • Hospital Univ.Virgen de la Victoria
      • Murcia, Spain, 30008
        • Hospital General Univ. Morales Meseguer
      • Málaga, Spain, 29010
        • Hospital Regional Univ. Málaga
      • Móstoles, Spain, 28933
        • Hospital Rey Juan Carlos I
      • Palma, Spain, 07120
        • Hospital Univ. Son Espases
      • Palma, Spain, 07198
        • Hospital Son Llatzer
      • Pamplona, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Salamanca, Spain, 37007
        • Hospital Clínico Univ. Salamanca
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Univ. de Santiago
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Univ. Virgen del Rocio
      • Terrassa, Spain, 08221
        • Hospital Univ. Mútua de Terrasa
      • Usansolo, Spain, 48960
        • Hospital de Galdakao
      • Valencia, Spain, 46026
        • Hospital Univ. Fe
      • Valladolid, Spain, 47003
        • Hospital Clínico Univ. Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic variables of the investigator
Time Frame: 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
Day 1
Socio-demographic variables of the patient
Time Frame: Day 1
Descriptive analysis of socio-demographic variables including age, gender, employment status, marital status, educational level
Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21
Time Frame: Day 1
Day 1
Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30
Time Frame: Day 1
Day 1
Clinical characteristics of patients - time since first therapeutic intervention
Time Frame: Day 1
Day 1
Health status as perceived by the patient
Time Frame: 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.
Day 1
Clinical assessment of patient's health status by the investigator
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ES-52030-351
  • IPS-ANT- 2015-01 (Other Identifier: Spanish Drug Agency AEMPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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