CaregiversCONDOL01NCT02861625
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
An observational study of Caregivers, run by Institut Paoli-Calmettes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- Letter of condolence and post-death medical consultation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 432 participants
- Where
- 2 sitesFrance
- Study dates
- 24 May 2018to 11 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- The physician already met with the caregiver after the patient's death
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Paoli Calmettes
Marseille, Bouches du Rhone, 13009
GRAVIS
Marseille
About this study
Official title: 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.
Read the 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.
- Conditions
- Caregivers
- Being tested
- Letter of condolence and post-death medical consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter of condolence and post-death medical consultationBehavioural
Process of sending a letter of condolence with consultation proposition.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 1 year post death
Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire
Measured: 1 year post death
Anxiety of the caregivers after the death of the patient
Evaluated by Spielberger State Trait anxiety questionnaire
Measured: 1 year post death
Depression of the caregivers after the death of the patient
Evaluated by Hospital Anxiety and Depression Scale
Measured: 1 year post death
Complicated grief
Evaluated by Inventory of complicated grief questionnaire
Measured: 1 year post death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start24 May 2018
- Primary completion11 Aug 2023
- Study completion11 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Family based
- Time perspective
- Prospective
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaelle Gravis, MS, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861625
- Sponsor's protocol ID
- CONDOL01-IPC 2015-006
- Acronym
- CONDOL01
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2016
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02861625
- Acronym / sponsor ID
- CONDOL01 / CONDOL01-IPC 2015-006
- Conditions
- Caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2024 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Behavioral: Letter of condolence and post-death medical consultationletter of condolence offering to the reliable person a post-death consultation with the reference physician (sent between J15 and J30 post death) |
| Group B | – | –no intervention, i.e without a letter of condolence proposing a consultation with the reference physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- The physician already met with the caregiver after the patient's death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letter of condolence and post-death medical consultationProcess of sending a letter of condolence with consultation proposition. | Behavioural | Group A |
Primary outcome
Evolution of mental component score (MCS) of the SF-12 questionnaire
Time frame: 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).
5 secondary outcomes
Quality of life of the caregivers after the death of the patient evaluated by specific caregivers CarGOQoL questionnaire
Time frame: 1 year post death
Quality of life of the caregivers after the death of the patient evaluated by SF12 questionnaire
Time frame: 1 year post death
Anxiety of the caregivers after the death of the patient
Time frame: 1 year post death
Depression of the caregivers after the death of the patient
Time frame: 1 year post death
Complicated grief
Time frame: 1 year post death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaelle Gravis, MS principal investigator
Institut Paoli-Calmettes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregivers, run by Institut Paoli-Calmettes at 2 sites 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 3 inclusion and 1 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evolution of mental component score (MCS) of the SF-12 questionnaire (time frame: 3 months post death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.