Clinical trial · Observational
Evaluation of the Quality of Life and Tolerance of Patients Treated With Vectorized Internal Radiotherapy (RIV) for a Neuro Endocrine Tumor (NET) in the Auvergne-Rhône-Alpes Region.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study consists of having participants complete quality of life questionnaires (PROMs) at the time of the cures +/- one week and in the middle of the intercure time +/- one week. As all the collection times do not correspond to a consultation or a visit to a medical service, The investigator wanted to develop a remote, computerized data collection solution. Researchers have programmed an AURA-RIV-TNE care pathway (MOCAs: Engine for the organization and coordination of health acts) on the myHCL patient environment, taking up the course of the study presented in the form of a table in paragraph 6.2. Once the patient consents to participate in the study, he must create an account on the patient interface of his investigation center (myHCL, myCHUGA etc) as much as possible to facilitate data extraction. Once the patient consents to participate in the study, the MOCAs AURA-RIV-TNE course will be associated with him in the Easily software, by defining the date week 0 (baseline) of the first treatment. This will allow automated sending of MAIL and SMS reminders at each questionnaire time. The MAILs will contain an internet link allowing the participant to be directly written to the questionnaires to be completed. A reminder system will be possible if the patient does not complete the questionnaire.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Neuroendocrine Tumour | Neuroendocrine Tumor | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Major subjects, suffering from metastatic neuroendocrine tumours
- description
- Major subjects, suffering from metastatic neuroendocrine tumours, for whom the indication for treatment by vectorized internal radiotherapy is decided in a multidisciplinary consultation meeting (National Reference Network for the management of Neuro-Endocrine Tumors) and who will be treated in one of the 5 centers in the AURA region
Primary outcomes (1)
- measure
- The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale
- timeFrame
- Collection time: Week 0 (baseline) and 1 year
- description
- The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable
Secondary outcomes (2)
- measure
- Analysis of quality of life at baseline (week 0)
- timeFrame
- Collection time: Week 0 (baseline)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years; * Patient starting treatment with RIV validated in the RENATEN RCP; * Patient having received written information about the study; * Collection of the patient's non-objection * Patients for whom treatment with RIV is administered within the framework of a clinical trial, may be included in the AURARIV-TNE study according to the written indications written in the 2 nd protocol of the sponsor of the clinical trial; * Patients undergoing re-treatment with RIV can be included; Exclusion Criteria: * Persons deprived of their liberty by a judicial or administrative decision; * Adults subject to a legal protection measure (guardianship, curatorship);
References
Publications (0)
Data not yet available