Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

Overview

The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

Full Title of Study: “The Fami-Life Study: Protocol of a Prospective Multicenter Observational Mixed Study of Psychological Consequences of Grieving Families in French Palliative Care Units on the Behalf of the F.R.I.P.C Research Network”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 1, 2020

Detailed Description

There is hardly knowledge on how bereavement is treated in palliative care patient's relatives. The field of bereavement needs studies that validate the theoretical underpinning of the research area. This study will depict the grieving process of individuals having lost a relative in palliative care in France. Having baseline data of incidence of prolonged grief, risk factors of relative's prolonged grief and identification of risk factors associated with the management of end-of-life issues in palliative care will contribute to target interventions that should help decrease bereaved families burden. The investigator designed a quantitative study to assess the psychological effect of families after the death of the patient in palliative care unit and a qualitative study to examine the grieving prolonged process.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of prolonged grief in bereaved family members
    • Time Frame: 6 months after patient’s death in palliative care unit
    • Inventory Grief Disorder > 25
  • Risk factors of prolonged grief in bereaved family members
    • Time Frame: 6 months after patient’s death in palliative care unit
    • Hierarchical logistic regression models with a random effect center after selection of variables by univariate analysis then introduced in a multivariate analysis

Secondary Measures

  • Post traumatic stress disorder in bereaved family members
    • Time Frame: 6 months after patient’s death in palliative care unit
    • Impact of event Scale-revised > 22
  • Anxiety and depression symptoms in bereaved family members
    • Time Frame: 6 months after patient’s death in palliative care unit
    • Hospital anxiety and depression scale ≥ 8
  • Anxiety and depression symptoms in family members
    • Time Frame: Between between day 3 and day 5 after patient admission in the palliative care unit
    • Hospital anxiety and depression scale ≥ 8
  • Report of the families’ grief experience in those who have signs of prolonged grief according to the Inventory of Complicated Grief questionnaire with a score > 25
    • Time Frame: Between 6 and 12 months after the patient’ death.
    • Interpretative Phenomenological Analysis

Participating in This Clinical Trial

Inclusion Criteria

  • Families of adult patients hospitalized more than 72 hours in a palliative care unit for end-of-life care. – Eligibility of end-of-life cares are defined after the first evaluation by the palliative care physician. Exclusion Criteria:

  • Patients with less than 72 hours of life-expectancy – Patients or families who refused the study – Patients or families included in a study using the same questionnaires – Patients without families visiting them in the first 24 hours after admission – Patients not hospitalized for end-of-life issues – Families not fluent in French – Deaf or mute families

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hôpital Franco-Britannique-Fondation Cognacq-Jay
  • Collaborator
    • Fondation de France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maité Garrouste-Orgeas, MD, Director, head of clinical research, principal investigator, medical doctor – Hôpital Franco-Britannique-Fondation Cognacq-Jay
  • Overall Official(s)
    • Jean-François Timsit, MD, PhD, Study Chair, INSERM 1137, IAME, Paris Diderot University, Paris

Citations Reporting on Results

Fasse L, Flahault C, Bredart A, Dolbeault S, Sultan S. Describing and understanding depression in spouses of cancer patients in palliative phase. Psychooncology. 2015 Sep;24(9):1131-7. doi: 10.1002/pon.3777. Epub 2015 Feb 24.

Kentish-Barnes N, Chaize M, Seegers V, Legriel S, Cariou A, Jaber S, Lefrant JY, Floccard B, Renault A, Vinatier I, Mathonnet A, Reuter D, Guisset O, Cohen-Solal Z, Cracco C, Seguin A, Durand-Gasselin J, Eon B, Thirion M, Rigaud JP, Philippon-Jouve B, Argaud L, Chouquer R, Adda M, Dedrie C, Georges H, Lebas E, Rolin N, Bollaert PE, Lecuyer L, Viquesnel G, Leone M, Chalumeau-Lemoine L, Garrouste M, Schlemmer B, Chevret S, Falissard B, Azoulay E. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015 May;45(5):1341-52. doi: 10.1183/09031936.00160014. Epub 2015 Jan 22.

Flahault C, Dolbeault S, Sankey C, Fasse L. Understanding grief in children who have lost a parent with cancer: How do they give meaning to this experience? Results of an interpretative phenomenological analysis. Death Stud. 2018 Sep;42(8):483-490. doi: 10.1080/07481187.2017.1383951. Epub 2018 Jan 24.

Fasse L, Sultan S, Flahault C, Mackinnon CJ, Dolbeault S, Bredart A. How do researchers conceive of spousal grief after cancer? A systematic review of models used by researchers to study spousal grief in the cancer context. Psychooncology. 2014 Feb;23(2):131-42. doi: 10.1002/pon.3412. Epub 2013 Sep 30.

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