Perception of Information and Quality of Life in Neuroendocrine Tumour on Lanreotide Autogel

Study Overview
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Brief Summary
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The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.

Official Title
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Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastroenteropancreatic neuroendocrine tumor (GEPNET), histologically proven, grade 1 or 2, Subject eligible for antitumor treatment initiation with lanreotide autogel*, alone or combined with other therapies, selected freely and prior to inclusion in the study by the physician, Subject able to complete a self-administered evaluation questionnaire during initiation visit and liable to be seen again within 6 months of the initial visit based on the physician's usual practices Having consented in writing to his/her data being accessed for participation in the study. Exclusion Criteria: Previously treated by lanreotide autogel Simultaneously participating in a clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|The study is an observational evaluation that does not affect physician practices, the physician-patient relationship, or the care of subjects. The prescriptions will be decided prior to inclusion of the subject into the study. The information will be recorded using the data available in the medical file or collected during the visit (as part of the routine subject management).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute variation on the score (standardized on a scale from 0 to 100) of the 3 targeted dimensions (disease, treatments and supportive care) of the self-administered Quality of Life Questionnaire (QLQ) QLQINFO25 |  | Change from Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Month 3 of the 3 targeted dimensions (disease, treatments and supportive care (ie, other services)) of QLQ-INFO25 self-administered questionnaire |  | Change from Baseline to Month 3 | 
| Changes from baseline to Month 3 and Month 6 on dimensions of the QLQ-INFO25 self-administered questionnaire not part of the primary endpoint |  | Change from Baseline to Month 3 and 6 | 
| Change from baseline to Month 3 and Month 6 in quality of life using QLQ-C30 questionnaire |  | Change from Baseline to Month 3 and Month 6 | 
| Changes of symptoms assessments (presence of symptoms or not) as part of the monitoring of the Neuroendocrine Tumor (NET) |  | Change from Baseline to Month 3 and to Month 6 | 
| Changes of biochemical markers expressed in terms of results (decrease, stable, increase) as part of the monitoring of the NET |  | Change from Baseline to Month 3 and to Month 6 | 
| Progression (yes/no) of NET on imaging as part of the monitoring of the NET |  | Month 3 and Month 6 |