Prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the Family Research in Palliative Care (F.R.I.P.C research network)

Background. Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. This study aims to assess the psychological consequences of grieving relatives after patients’ death in French palliative care units and their needs for support.

Methods. This is a prospective observational multicenter mixed study. Relatives of adult patients with a neoplasia expected to be hospitalized more than 72 hours in a palliative care unit for end-of-life issues will be included within 48 hours after patient admission. End-of-life issues are defined by the physician at patient admission. Relatives who are not able to have a phone call at 6-months are excluded. The primary outcome is the incidence of prolonged grief reaction defined by an ICG (Inventory Complicate Grief) > 25 (0 best-76 worst) at 6 months after patient’ death. Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients’ death based on an Hospital Anxiety and Depression score (range 0-42) > 8 for each subscale (minimal clinically important difference: 2.5), post-traumatic stress disorder symptoms 6 months after patient’ death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, specifically built for the study. Between 6 and 12 months after the patient’s death, a phone interview with relatives with prolonged grief reactions will be planned by a psychologist to understand the complex system of grief. It will be analyzed with the Interpretative Phenomenological Analysis. We planned to enroll 500 patients and their close relatives assuming a 25% prolonged grief rate and a 6-month follow-up available in 60% of relatives.

 

Thèmes
Disciplines
Mots-clés
  • Proches et familles
Publications issues de ce projet

The Fami-Life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the Family Research in Palliative Care (F.R.I.P.C research network).BMC Palliative Care 2019; 18:111

Acronyme
FAMI-LIFE
N° de projet (ANR, clinical trials…)
NCT03748225 registered on 11/19/2018
Date de début
2019
Statut
en cours de réalisation
Financeurs
  • Fondation de France
Nom de l'appel à projet
  • Soigner, soulager, accompagner : projets de recherche
Établissement porteur du projet
  • Hôpital Franco-Britannique
Responsable(s) du projet
GARROUSTE-ORGEAS Maité
Équipe projet
Structures partenaires
Paris university, IAME, INSERM, F-75018
Paris university, Psychology laboratory and work process
Grenoble Alpes University, INSERM, CHU Grenoble Alpes, HP2, Grenoble
Contact
Maité Garrouste-Orgeas
maite.garrouste@ihfb.org
33 6 80 06 22 68