- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053918
Research-Action in Hematology From Hospitalization to Home (RAH HD)
Psychological Follow-up in a Protected Hematology Unit as a Transitional Device Between Hospitalization and Return Home
Objective :
To study and support the hospitalization and the return home of patients with the help of a psychological follow-up started in a hospital institution and which will continue in the patient's home, based on the concepts of transitionality and narrativity.
Material and method To do this, the subjects will benefit from psychological interviews where they will freely discuss what concerns them, whether it is illness, treatment, returning home, or any other personal subject.
They will be divided into two groups of 5 patients each, one of the groups will benefit from follow-up in an institution as contracted for several years between the Institute of Hematology and the psychologists of the UMDSP, another from the same follow-up but with the presence of the psychologist at the time of discharge extended to the patient's home after leaving the hospital for a period of 2 months.
To ensure a certain consistency in the evaluation criteria, these will be standardized in the form of questionnaires completed blindly by the patient, a caregiver and the investigator, at 3 key times of the research (entry, discharge from hospital, two months after this discharge)
Device tested:
The aim of this work is to test the benefits of a device based on transitionality, which can limit, thanks to the restoration of the symbolization process, the deleterious effects of each of the stages imposed by the disease, the care and the resumption of autonomy once the active phase of care has passed.
Narrativity is also at the heart of this transitional device. It makes it possible to evoke the present experience of the patient in connection with future projects and in the continuity of past, potentially traumatic events. It opens onto a dynamic temporal perspective where the trauma freezes.
The whole process promotes the subjective reappropriation of the experience and a psychic well-being.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Caen, France
- Caen University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient hospitalized Protected Hematology Unit
- patient with haematologic cancer
- patient requesting psychological assistance or accepting proposed psychological assistance
- signed informed consent
Exclusion Criteria:
- patient refusing to participate
- patient not able to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
classic follow-up (Group A)
Group A will benefit from the classic follow-up, as it has been contractualized for several years now between the UMDSP and the hematology sector.
Namely a psychological follow-up in the patient's room during the hospitalization time, once a week, more if the patient is going through a difficult passage that requires closer support.
This follow-up is spread over an approximate period of 6 weeks maximum, depending on the length of hospitalization
|
|
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Intervention group (Group B)
Group B will benefit from this same follow-up, to which will be added an interview when leaving the sector, and the extension of follow-up of the patient at home according to the same conditions: once a week, more if necessary, over a period of two months.
This follow-up is spread over an approximate period of 15 weeks maximum, depending on the length of hospitalization.
|
additional interview when leaving the sector, and the extension of follow-up of the patient at home
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation of the psychological state, anxiety-depressive disorders
Time Frame: At hospital Month 0 and at home Month 2
|
anxiety-depressive disorders yes or no
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At hospital Month 0 and at home Month 2
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-199
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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