CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient (CONDOL01)
6. juli 2026 opdateret af: Institut Paoli-Calmettes
CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial
The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process.
In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective).
It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
432
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Marseille, Frankrig
- GRAVIS
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Bouches Du Rhone
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Marseille, Bouches Du Rhone, Frankrig, 13009
- Institut Paoli Calmettes
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population consisted of the reliable person (a family member and/or caregiver, designed by the patient himself at each hospitalization) of cancer patients who have died in one of the participating center.
Beskrivelse
Inclusion Criteria:
- Patient died in the institution
- Patient for which the reliable person has been identified
- Acceptation of the reference physician to send a letter of condolence with the proposed consultation
Exclusion Criteria:
- The physician already met with the caregiver after the patient's death
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Group A
letter of condolence offering to the reliable person a post-death consultation with the reference physician (sent between J15 and J30 post death)
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Process of sending a letter of condolence with consultation proposition.
|
|
Group B
no intervention, i.e without a letter of condolence proposing a consultation with the reference physician
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of mental component score (MCS) of the SF-12 questionnaire
Tidsramme: 3 months post death
|
It will be evaluated by self-questionnaires send at 3 months after the death of the patient, in the 2 groups (with or without condolence letter proposing a post-death consultation).
|
3 months post death
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire
Tidsramme: 1 year post death
|
1 year post death
|
|
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Anxiety of the caregivers after the death of the patient
Tidsramme: 1 year post death
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Evaluated by Spielberger State Trait anxiety questionnaire
|
1 year post death
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Depression of the caregivers after the death of the patient
Tidsramme: 1 year post death
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Evaluated by Hospital Anxiety and Depression Scale
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1 year post death
|
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Complicated grief
Tidsramme: 1 year post death
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Evaluated by Inventory of complicated grief questionnaire
|
1 year post death
|
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Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire
Tidsramme: 1 year post death
|
1 year post death
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gwenaelle Gravis, MS, Institut Paoli-Calmettes
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. maj 2018
Primær færdiggørelse (Faktiske)
11. august 2023
Studieafslutning (Faktiske)
11. august 2024
Datoer for studieregistrering
Først indsendt
1. august 2016
Først indsendt, der opfyldte QC-kriterier
9. august 2016
Først opslået (Anslået)
10. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CONDOL01-IPC 2015-006
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