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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853422
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
Gastrointestinal Neuroendocrine Tumours

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : April 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017





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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21 [ Time Frame: Day 1 ]
  4. Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30 [ Time Frame: Day 1 ]
  5. Clinical characteristics of patients - time since first therapeutic intervention [ Time Frame: Day 1 ]
  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853422


Locations
Show Show 32 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02853422    
Other Study ID Numbers: A-ES-52030-351
IPS-ANT- 2015-01 ( Other Identifier: Spanish Drug Agency AEMPS )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases