NCT06053918

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
Last Updated

September 26, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

July 28, 2023

Last Update Submit

September 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of the psychological state, anxiety-depressive disorders

    anxiety-depressive disorders yes or no

    At hospital Month 0 and at home Month 2

Study Arms (2)

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

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.

Other: additional follow-up extension at home

Interventions

additional interview when leaving the sector, and the extension of follow-up of the patient at home

Intervention group (Group B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patient in Protected Hematology Unit

You may qualify if:

  • patient hospitalized Protected Hematology Unit
  • patient with haematologic cancer
  • patient requesting psychological assistance or accepting proposed psychological assistance
  • signed informed consent

You may not qualify if:

  • patient refusing to participate
  • patient not able to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAEN University Hospital

Caen, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2023

First Posted

September 26, 2023

Study Start

May 7, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2021

Last Updated

September 26, 2023

Record last verified: 2023-07

Locations