Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

NCT03748225 | Completed DMC

• 1 other identifier: IHFB-002
• Study Type: observational
• Target: 609
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bereaved Families

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Post traumatic stress disorder in bereaved family members

  6 months after patient's death in palliative care unit

• Anxiety and depression symptoms in bereaved family members

  6 months after patient's death in palliative care unit

• Anxiety and depression symptoms in family members

  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

  Between 6 and 12 months after the patient' death.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Franco-Britannique-Fondation Cognacq-Jay: lead
• Fondation de France: collaborator

Study Sites (1)

French British Institute

Levallois-Perret, 92300, France

Location

Related Publications (5)

• 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.

  PMID: 25707938 RESULT

• 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.

  PMID: 25614168 RESULT

• 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.

  PMID: 29173097 RESULT

• 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.

  PMID: 24115499 RESULT

• 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.

  PMID: 31818281 DERIVED

Study Officials

• Jean-François Timsit, MD, PhD

  INSERM 1137, IAME, Paris Diderot University, Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, head of clinical research, principal investigator, medical doctor

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 20, 2018
• Study Start: February 4, 2019
• Primary Completion: October 1, 2020
• Study Completion: February 10, 2021
• Last Updated: February 11, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)