Gastrointestinal Neuroendocrine Tumours
Conditions
Brief summary
The purpose of this study is to evaluate the utility of the QLQ-GINET21 in making clinical and therapeutic decisions.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survey on the clinical utility of the QLQ-GINET21, which the investigator is to complete for each patient enrolled | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Patients' health-related quality of life concerning gastrointestinal neuroendocrine using QLQ-C30 | Day 1 | — |
| 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 |
| 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. |
| 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 | — |
Countries
Portugal, Spain
Outcome results
None listed