Incidence and Risk Factors of Prolonged Grief in Palliative Care Units (FAMI-LIFE)

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

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.

Study Overview

• Status: Completed
• Conditions: Bereaved Families

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.

• Study Type: Observational
• Enrollment (Actual): 609

Contacts and Locations

Study Locations

• France
  • Levallois-Perret, France, 92300
    • French British Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participating palliative care units belong to the French Society of Palliative Care (SFAP) and are selected using the list of the different French units on their website. An invitation of participation is sent to the clinical responsible of each unit.

The participating units belong to university, community and private hospitals.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post traumatic stress disorder in bereaved family members	Impact of event Scale-revised > 22	6 months after patient's death in palliative care unit
Anxiety and depression symptoms in bereaved family members	Hospital anxiety and depression scale ≥ 8	6 months after patient's death in palliative care unit
Anxiety and depression symptoms in family members	Hospital anxiety and depression scale ≥ 8	Between between day 3 and day 5 after patient admission in the palliative care unit
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	Interpretative Phenomenological Analysis	Between 6 and 12 months after the patient' death.

Collaborators and Investigators

• Sponsor: GCS IHFB Cognacq-Jay
• Collaborators: Fondation de France
• Investigators: Study Chair: Jean-François Timsit, MD, PhD, INSERM 1137, IAME, Paris Diderot University, Paris

Publications and helpful links

General Publications

• 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.
• Garrouste-Orgeas M, Flahault C, Poulain E, Evin A, Guirimand F, Fossez-Diaz V, Perruchio S, Verlaine C, Vanbesien A, Kaczmarek W, Birkui de Francqueville L, De Lariviere E, Bouquet G, Copel L, Verliac V, Marche V, Mathias C, Gracia D, Mhalla A, Michonneau-Gandon V, Poupardin C, Touzet L, Ranchou G, Guastella V, Richard B, Bienfait F, Sonrier M, Michel D, Ruckly S, Bailly S, Timsit JF. 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 Palliat Care. 2019 Dec 9;18(1):111. doi: 10.1186/s12904-019-0496-4.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IHFB-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No