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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Neuroendocrine Tumour
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
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);
Outcomes
Primary Outcomes
The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale
Time Frame: Collection time: Week 0 (baseline) and 1 year
The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable
Secondary Outcomes
- Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion, during the treatment and at 12 months.(Time of collection: Week 0 (baseline), 6 months and 1 year)
- Analysis of quality of life at baseline (week 0)(Collection time: Week 0 (baseline))