AzTrials
AzTrials

Bereaved FamiliesFAMI-LIFENCT03748225

Incidence and Risk Factors of Prolonged Grief in Palliative Care Units

An observational study of Bereaved Families, run by Hôpital Franco-Britannique-Fondation Cognacq-Jay at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bereaved Families
How many people
609 participants
Where
1 siteFrance
Study dates
4 Feb 2019to 10 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • French British Institute

    Levallois-Perret, 92300

Other trials in France

About this study

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

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of prolonged grief in bereaved family members

    Inventory Grief Disorder > 25

    Measured: 6 months after patient's death in palliative care unit

  2. 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

    Measured: 6 months after patient's death in palliative care unit

Secondary outcomes (4)

  1. Post traumatic stress disorder in bereaved family members

    Impact of event Scale-revised > 22

    Measured: 6 months after patient's death in palliative care unit

  2. Anxiety and depression symptoms in bereaved family members

    Hospital anxiety and depression scale ≥ 8

    Measured: 6 months after patient's death in palliative care unit

  3. Anxiety and depression symptoms in family members

    Hospital anxiety and depression scale ≥ 8

    Measured: Between between day 3 and day 5 after patient admission in the palliative care unit

  4. 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

    Measured: Between 6 and 12 months after the patient' death.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start4 Feb 2019
  3. Primary completion1 Oct 2020
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03748225
Sponsor's protocol ID
IHFB-002
Acronym
FAMI-LIFE
Status last verified
Jan 2020
First submitted
19 Nov 2018
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25707938

  • 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.

    PubMed 25614168

  • 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.

    PubMed 29173097

  • 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.

    PubMed 24115499

  • Garrouste-Orgeas M, Marche V, Pujol N, Michel D, Evin A, Fossez-Diaz V, Perruchio S, Vanbesien A, Verlaine C, Copel L, Kaczmarek W, Birkui de Francqueville L, Michonneau-Gandon V, de Lariviere E, Poupardin C, Touzet L, Guastella V, Mathias C, Mhalla A, Bouquet G, Richard B, Gracia D, Bienfait F, Verliac V, Ranchou G, Kirsch S, Flahault C, Loiodice A, Bailly S, Ruckly S, Timsit JF. Incidence and risk factors of prolonged grief in relatives of patients with terminal cancer in French palliative care units: The Fami-Life multicenter cohort study. Palliat Support Care. 2024 Oct;22(5):961-970. doi: 10.1017/S1478951523000111.

    PubMed 36878669

  • 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.

    PubMed 31818281

Questions about this trial

What is this clinical trial studying?

An observational study of Bereaved Families, run by Hôpital Franco-Britannique-Fondation Cognacq-Jay at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of prolonged grief in bereaved family members (time frame: 6 months after patient's death in palliative care unit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748225, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in