NCT Number: NCT02853422
Quality-Of-Life QLQ-GINET21 Questionnaire In The Treatment Of Patients With Gastrointestinal Neuroendocrine Tumours
The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Instituto Portuguès de Oncologia de Lisboa, Lisbon, Portugal
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
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Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled
Time frame: Day 1
Secondary outcomes
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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
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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
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Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-GINET21
Time frame: Day 1
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Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30
Time frame: Day 1
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Clinical characteristics of patients - time since first therapeutic intervention
Time frame: Day 1
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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.
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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.
Sponsors and collaborators
Lead sponsor
Ipsen
Industry
Registry information
Official study 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
Acronym: QUALINETS
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 2, 2016
- Registry last updated
- Nov 5, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.