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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)

Maité Garrouste-Orgeas 1 Cécile Flahault 2 Edith Poulain Adrien Evin 3 Frédéric Guirimand 4 Virginie Fossez-Diaz Ségolène Perruchio Catherine Verlaine 5 Anne Vanbésien 6 Willeme Kaczmarek 7 Laurence Birkui de Francqueville 8 Emmanuel de Larivière Guillaume Bouquet 9 Laure Copel 10 Virginie Verliac Véronique Marché Carmen Mathias 11 Dominique Gracia 12 Alaa Mhalla 13 Véronique Michonneau-Gandon 14 Cécile Poupardin 15, 16 Licia Touzet 17 Gaelle Ranchou 18 Virginie Guastella 19 Bruno Richard 20, 21 Florent Bienfait 22 Marie Sonrier 23 Dominique Michel Stephane Ruckly 24 Sébastien Bailly 25 Jean-François Timsit 26, 27
26 INSERM U823, équipe 11 (Epidémiologie des cancers et des affections graves)
INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble, Clinique de réanimation médicale
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.
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Submitted on : Friday, June 11, 2021 - 10:04:37 AM
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Maité Garrouste-Orgeas, Cécile Flahault, Edith Poulain, Adrien Evin, Frédéric Guirimand, et al.. 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, BioMed Central, 2019, 18 (1), ⟨10.1186/s12904-019-0496-4⟩. ⟨hal-02526838⟩

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