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)

Autor: Véronique Michonneau-Gandon, Laure Copel, Virginie Verliac, Dominique Gracia, Gaelle Ranchou, Willeme Kaczmarek, Emmanuel De Larivière, Maité Garrouste-Orgeas, Adrien Evin, Virginie Guastella, Catherine Verlaine, Frédéric Guirimand, Jean-François Timsit, Alaa Mhalla, Florent Bienfait, Licia Touzet, Guillaume Bouquet, Marie Sonrier, Laurence Birkui de Francqueville, Ségolène Perruchio, Cécile Flahault, Anne Vanbésien, Sébastien Bailly, Carmen Mathias, Virginie Fossez-Diaz, Edith Poulain, Stéphane Ruckly, Véronique Marché, Cécile Poupardin, Dominique Michel, Bruno Richard
Přispěvatelé: Salvy-Córdoba, Nathalie, Epidémiologie pronostique des cancers et affections graves, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Psychopathologie et Processus de Santé (LPPS - EA 4057), Université Paris Descartes - Paris 5 (UPD5), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de recherche Versailles Saint-Quentin Institutions Publiques (VIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), CH de Troyes, Centre Hospitalier [Douai, Nord], Centre Hospitalier de la Dracénie [Draguignan], Centre Hospitalier Compiègne-Noyon, Centre Hospitalier Tourcoing, Groupe Hospitalier Diaconesses Croix Saint-Simon, Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), Hopital de Salon d eProvence, AP-HP Hôpital A. Chenevier [Créteil], Centre Hospitalier Intercommunal Castres-Mazamet, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hopital de Périgueux (CH Périgueux), Hopital de Périgueux, Centre de Soins Palliatifs [CHU Clermont-Ferrand] (CSP), CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Informatique et Distribution (ID-IMAG), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National Polytechnique de Grenoble (INPG)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Institut de psychiatrie et neurosciences de Paris (IPNP - U1266 Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut d'oncologie/développement Albert Bonniot de Grenoble (INSERM U823), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM), INSERM U823, équipe 11 (Epidémiologie des cancers et des affections graves), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM)-Clinique de réanimation médicale, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon-Hôpital Michallon, CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)
Jazyk: angličtina
Rok vydání: 2019
Předmět:
medicine.medical_specialty
Palliative care
media_common.quotation_subject
lcsh:Special situations and conditions
[SDV.NEU.PC] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior
[SDV.CAN]Life Sciences [q-bio]/Cancer
Anxiety
Study Protocol
03 medical and health sciences
0302 clinical medicine
Clinical Protocols
[SDV.CAN] Life Sciences [q-bio]/Cancer
Surveys and Questionnaires
Humans
Medicine
Family
Prospective Studies
030212 general & internal medicine
Psychiatry
Depression (differential diagnoses)
media_common
Interpretative phenomenological analysis
[SDV.NEU.PC]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Psychology and behavior
business.industry
Minimal clinically important difference
Incidence (epidemiology)
lcsh:RC952-1245
Post-traumatic
General Medicine
Stress disorders
Relatives
3. Good health
030220 oncology & carcinogenesis
Grief
Observational study
France
medicine.symptom
business
Zdroj: BMC Palliative Care
BMC Palliative Care, 2019, 18 (1), ⟨10.1186/s12904-019-0496-4⟩
BMC Palliative Care, Vol 18, Iss 1, Pp 1-8 (2019)
BMC Palliative Care, BioMed Central, 2019, 18 (1), ⟨10.1186/s12904-019-0496-4⟩
ISSN: 1472-684X
Popis: 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 h in a palliative care unit for end-of-life issues will be included within 48 h 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. Discussion This study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units. Evaluating relatives’ experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs. Trial registration NCT03748225 registered on 11/19/2018. Recruiting patients.
Databáze: OpenAIRE
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