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.

Last updated: June 10, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abdominal Cancer

Digestive System Neoplasms

Carcinoid Syndrome And Carcinoid Tumours

Treatment

N/A

Clinical Study ID

NCT06043193
69HCL23_0367
2023-A01344-41
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 aclinical trial, may be included in the AURARIV-TNE study according to the writtenindications written in the 2 nd protocol of the sponsor of the clinical trial;

  • Patients undergoing re-treatment with RIV can be included;

Exclusion

Exclusion Criteria:

  • Persons deprived of their liberty by a judicial or administrative decision;

  • Adults subject to a legal protection measure (guardianship, curatorship);

Study Design

Total Participants: 100
Study Start date:
February 20, 2024
Estimated Completion Date:
September 20, 2026

Study 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.

Connect with a study center

  • CHU de Saint-Etienne, Hôpital Nord

    Saint Priest en Jarez, Saint-Etienne 42270
    France

    Active - Recruiting

  • CH Métropole Savoie

    Chambery, 73000
    France

    Active - Recruiting

  • Centre de Lutte Contre le Cancer Jean Perrin

    Clermont-Ferrand, 63011
    France

    Active - Recruiting

  • Hospices Civils de Lyon, Hopital Lyon Sud

    Lyon, 69495
    France

    Active - Recruiting

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