Clinical trial NCT06043193: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Neuroendocrine Tumour
Keywords: IRV, Neuroendocrin, Quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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);

Primary outcomes:
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
Secondary outcomes:
measure: Analysis of quality of life at baseline (week 0)
timeFrame: Collection time: Week 0 (baseline)
measure: Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion, during the treatment and at 12 months.
timeFrame: Time of collection: Week 0 (baseline), 6 months and 1 year
Other outcomes:
Locations:
city: Saint Priest en Jarez
country: France
facility: CHU de Saint-Etienne, Hôpital Nord
state: Saint-Etienne
city: Chambery
country: France
facility: CH Métropole Savoie
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean Perrin
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hopital Lyon Sud
Study officials:
References: