Hematologic CancerRAH HDNCT06053918
Research-Action in Hematology From Hospitalization to Home
An observational study of Hematologic Cancer, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- additional follow-up extension at home
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2019to 31 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patient in Protected Hematology Unit
Who may be able to join
- patient hospitalized Protected Hematology Unit
- patient with haematologic cancer
- patient requesting psychological assistance or accepting proposed psychological assistance
- signed informed consent
Who cannot join
- patient refusing to participate
- patient not able to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Hematologic Cancer
- Being tested
- additional follow-up extension at home
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional follow-up extension at homeOther
additional interview when leaving the sector, and the extension of follow-up of the patient at home
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: additional follow-up extension at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the psychological state, anxiety-depressive disorders
anxiety-depressive disorders yes or no
Measured: At hospital Month 0 and at home Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053918
- Sponsor's protocol ID
- 18-199
- Acronym
- RAH HD
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Follow-up in a Protected Hematology Unit as a Transitional Device Between Hospitalization and Return Home
- ClinicalTrials.gov ID
- NCT06053918
- Acronym / sponsor ID
- RAH HD / 18-199
- Conditions
- Hematologic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 26 Sep 2023 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Other: additional follow-up extension at homeGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patient in Protected Hematology Unit
Key inclusion criteria (4 listed)
- patient hospitalized Protected Hematology Unit
- patient with haematologic cancer
- patient requesting psychological assistance or accepting proposed psychological assistance
- signed informed consent
Key exclusion criteria (2 listed)
- patient refusing to participate
- patient not able to participate
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 |
|---|---|---|
| additional follow-up extension at homeadditional interview when leaving the sector, and the extension of follow-up of the patient at home | Other | Intervention group (Group B) |
Primary outcome
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
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 26 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Cancer, run by University Hospital, Caen at 1 site 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 4 inclusion and 2 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical evaluation of the psychological state, anxiety-depressive disorders (time frame: At hospital Month 0 and at home Month 2). 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 26 Sep 2023.