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

NCT02861625 | Completed

• 1 other identifier: CONDOL01-IPC 2015-006
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Caregivers

Outcome Measures

Primary Outcomes (1)

• Evolution of mental component score (MCS) of the SF-12 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 Outcomes (5)

• 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 SF12 questionnaire

  1 year post death

• Anxiety of the caregivers after the death of the patient

  1 year post death

• Depression of the caregivers after the death of the patient

  1 year post death

• Complicated grief

  1 year post death

Study Arms (2)

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

Group B

no intervention, i.e without a letter of condolence proposing a consultation with the reference physician

Interventions

Letter of condolence and post-death medical consultation BEHAVIORAL

Process of sending a letter of condolence with consultation proposition.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The physician already met with the caregiver after the patient's death

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (2)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location

GRAVIS

Marseille, France

Location

Study Officials

• Gwenaelle Gravis, MS

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: May 24, 2018
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2024
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

FR (2)