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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01344-41 | Other Identifier | ID-RCB |
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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.
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.
The investigator 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major subjects, suffering from metastatic neuroendocrine tumours | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale | The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable | Collection time: Week 0 (baseline) and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of quality of life at baseline (week 0) | Analysis of quality of life at baseline (Week 0) according to patient demographic profile and the characteristics of the tumour. | Collection time: Week 0 (baseline) |
| Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion, during the treatment and at 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas JACQUET-FRANCILLON, MD | Contact | 4 72 35 69 99 | +33 | nicolas.jacquet-francillon@chu-lyon.fr |
| Adeline MANSUY | Contact | 4 72 11 51 70 | +33 | adeline.mansuy@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne, HĂ´pital Nord | Recruiting | Saint-Priest-en-Jarez | Saint-Etienne | 42270 | France |
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.Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion (before the first cycle-IVR1), during IVR (IVR2 to IVRn), at 6 and 12 months after IVR1, will be assessed by 4 questionnaires (EORTC QLQ-C30 + EORTC QLQ-GI.NET21 + EQ-5D + HADS) forming a composite criterion.and response to treatment. |
| Time of collection: Week 0 (baseline), 6 months and 1 year |
| CH Métropole Savoie | Recruiting | Chambéry | 73000 | France |
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| Centre de Lutte Contre le Cancer Jean Perrin | Recruiting | Clermont-Ferrand | 63011 | France |
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| Hospices Civils de Lyon, Hopital Lyon Sud | Recruiting | Lyon | 69495 | France |
|
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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