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)

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.

Study Overview

• Status: Unknown
• Conditions: Caregivers
• Intervention / Treatment: Behavioral: Letter of condolence and post-death medical consultation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 432

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Recruiting
    • GRAVIS
    • Contact: GRAVIS Gwenaëlle, MD
  • Bouches Du Rhone
    • Marseille, Bouches Du Rhone, France, 13009
      • Recruiting
      • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Behavioral: Letter of condolence and post-death medical consultation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of mental component score (MCS) of the SF-36 questionnaire	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire		1 year post death
Quality of life of the caregivers after the death of the patient evaluated by SF36 questionnaire		1 year post death
Anxiety of the caregivers after the death of the patient	Evaluated by Spielberger State Trait anxiety questionnaire	1 year post death
Depression of the caregivers after the death of the patient	Evaluated by Hospital Anxiety and Depression Scale	1 year post death
Complicated grief	Evaluated by Inventory of complicated grief questionnaire	1 year post death

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Gwenaelle Gravis, MS, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Anticipated): June 4, 2022
• Study Completion (Anticipated): June 4, 2022

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CONDOL01-IPC 2015-006