Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

Bereaved Families Clinical Trial

— FAMI-LIFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748225
• Other study ID #: IHFB-002
• Status: Completed
• Start date: February 4, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: January 2020
• Source: GCS IHFB Cognacq-Jay
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: February 10, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bereaved Families

Locations

Country	Name	City	State
France	French British Institute	Levallois-Perret

Sponsors (2)

Lead Sponsor	Collaborator
GCS IHFB Cognacq-Jay	Fondation de France

Country where clinical trial is conducted

France, 

References & Publications (4)

Fasse L, Flahault C, Brédart 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. — View Citation

Fasse L, Sultan S, Flahault C, Mackinnon CJ, Dolbeault S, Brédart 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): — View Citation

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: 1 — View Citation

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, Éon B, Thirion M, Rigaud JP, Philippon-Jouve B, Arg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of prolonged grief in bereaved family members	Inventory Grief Disorder > 25	6 months after patient's death in palliative care unit
Primary	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	Post traumatic stress disorder in bereaved family members	Impact of event Scale-revised > 22	6 months after patient's death in palliative care unit
Secondary	Anxiety and depression symptoms in bereaved family members	Hospital anxiety and depression scale = 8	6 months after patient's death in palliative care unit
Secondary	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
Secondary	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.