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1. 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)

Author

Maité Garrouste-Orgeas, Cécile Flahault, Edith Poulain, Adrien Evin, Frédéric Guirimand, Virginie Fossez-Diaz, Ségolène Perruchio, Catherine Verlaine, Anne Vanbésien, Willeme Kaczmarek, Laurence Birkui de Francqueville, Emmanuel De Larivière, Guillaume Bouquet, Laure Copel, Virginie Verliac, Véronique Marché, Carmen Mathias, Dominique Gracia, Alaa Mhalla, Véronique Michonneau-Gandon, Cécile Poupardin, Licia Touzet, Gaelle Ranchou, Virginie Guastella, Bruno Richard, Florent Bienfait, Marie Sonrier, Dominique Michel, Stéphane Ruckly, Sébastien Bailly, and Jean-François Timsit

Subjects
Palliative care, Stress disorders, Post-traumatic, Relatives, Anxiety, Grief, Special situations and conditions, RC952-1245
Abstract

Abstract 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.

Published
2019
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2. Incidence and risk factors of prolonged grief in relatives of patients with terminal cancer in French palliative care units: The Fami-Life multicenter cohort study

Author

Maité Garrouste-Orgeas, Véronique Marché, Nicolas Pujol, Dominique Michel, Adrien Evin, Virginie Fossez-Diaz, Ségolène Perruchio, Anne Vanbésien, Catherine Verlaine, Laure Copel, Willeme Kaczmarek, Laurence Birkui de Francqueville, Véronique Michonneau-Gandon, Emmanuel de Larivière, Cécile Poupardin, Licia Touzet, Virginie Guastella, Carmen Mathias, Alaa Mhalla, Guillaume Bouquet, Bruno Richard, Dominique Gracia, Florent Bienfait, Virginie Verliac, Gaelle Ranchou, Sylvie Kirsch, Cécile Flahault, Ambre Loiodice, Sébastien Bailly, Stéphane Ruckly, and Jean-François Timsit

Subjects
Psychiatry and Mental health, Clinical Psychology, General Medicine, General Nursing
Abstract

Objectives Psychological consequences of grief among relatives are insufficiently known. We reported incidence of prolonged grief among relatives of deceased patients with cancer. Methods Prospective cohort study of 611 relatives of 531 patients with cancer hospitalized for more than 72 hours and who died in 26 palliative care units was conducted. The primary outcome was prolonged grief in relatives 6 months after patient death, measured with the Inventory Complicated Grief (ICG > 25, range 0–76, a higher score indicates more severe symptoms) score. Secondary outcomes in relatives 6 months after patient death were anxiety and depression symptoms based on Hospital Anxiety and Depression Scale (HADS) score (range 0 [best]–42 [worst]), higher scores indicate more severe symptoms, minimally important difference 2.5. Post-traumatic stress disorder symptoms were defined by an Impact Event Scale-Revised score >22 (range 0–88, a higher score indicates more severe symptoms). Results Among 611 included relatives, 608 (99.5%) completed the trial. At 6 months, significant ICG scores were reported by 32.7% relatives (199/608, 95% CI, 29.0–36.4). The median (interquartile range ICG score) was 20.0 (11.5–29.0). The incidence of HADS symptoms was 87.5% (95% CI, 84.8–90.2%) at Days 3–5 and 68.7% (95% CI, 65.0–72.4) 6 months after patient’s death, with a median (interquartile range) difference of −4 (–10 to 0) between these 2 time points. Improvement in HADS anxiety and depression scores were reported by 62.5% (362/579) relatives. Significance of results These findings support the importance of screening relatives having risk factors of developing prolonged grief in the palliative unit and 6 months after patient’s death.

Published
2023

3. 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)

Author

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, 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), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)

Subjects
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
Abstract

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.

Published
2019

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