Informations générales (source: ClinicalTrials.gov)
Assessment and Prevention of Caregiver Burden in Oncology (PREPAC-01)
Interventional
N/A
Institut Cancerologie de l'Ouest (Voir sur ClinicalTrials)
juillet 2023
juin 2027
29 juin 2024
The goal of this randomized, open and controlled supportive care study is to see if we
can reduce the burden on the caregiver by offering the caregiver systematic and regular
support from the nurse (APN, nurse coordinator in French health care organisations)
compared to a support focused on the patient. At the same time, we will also evaluate the
impact of this personalised support for the caregiver on their anxiety and quality of
life.
Participants will caregivers of a patient who started a line (any line) of systemic
treatment for a solid tumour since less than 3 months or in an active palliative
situation since less than 1 month.
Researchers will compare 2 groups : a group where caregivers benefit from specific
nursing support and a group of caregivers with no specific nursing support.
The specific support includes 3 mandatory on-site nursing consultations with the
patient's caregiver and interviews once a month with a nurse either by phone, on-site
consultation or teleconsultation.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Antoine Lacassagne - 06 189 - Nice - France | julie OUDIN, Nurse | Contact (sur clinicalTrials) | |||
| Centre Henri Bequerel - 76038 - Rouen - France | Amel CONSTANTIN, Nurse | Contact (sur clinicalTrials) | |||
| CH Cholet - 49300 - Cholet - France | Margot NOBLECOURT, MD | Contact (sur clinicalTrials) | |||
| CH Mémorial de Saint Lo - 50000 - Saint Lo - France | Emillie LEFEVRE, Nurse | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44805 - Saint Herblain - France | Céline THOMAS, Nurse | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Caregiver designated by the patient;
- Caregiver of a patient who started a line (any line) of systemic treatment for a
solid tumour since less than 3 months or in an active palliative situation since
less than 1 month;
- Caregiver of patient already cared for by a nurse before inclusion or going to start
a nursing follow-up;
- Caregiver of a patient with a score ≥2 of social fragility and/or psychological
fragility and/or nutritional fragility and/or complexity;
- Caregiver designated by the patient;
- Caregiver of a patient who started a line (any line) of systemic treatment for a
solid tumour since less than 3 months or in an active palliative situation since
less than 1 month;
- Caregiver of patient already cared for by a nurse before inclusion or going to start
a nursing follow-up;
- Caregiver of a patient with a score ≥2 of social fragility and/or psychological
fragility and/or nutritional fragility and/or complexity;
- Patient whose life expectancy is assumed to be < 6 months;
- Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
- Caregiver declared as having a pathology that could alter his/her capacity to
support (psychiatric history, dementia...) or under guardianship.