Allogeneic DiseaseCABALLONCT03149952
A Pilot Study of the Feasibility of Setting up a Logbook for Allogeneic Haematopoietic Stem Cell Patients at the University Hospital of Amiens
A study testing Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells in people with Allogeneic Disease and Hematopoietic Stem Cell, run by Centre Hospitalier Universitaire, Amiens.
Trial summary
Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a particular time in the management of patients with malignant hemopathies both for the patient, for his entourage or for the nursing staff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Disease, Hematopoietic Stem Cell
- What is being tested?
- Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2017to 13 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- Major hospitalized patient for allogeneic haematopoietic stem cells
- Patient agreeing to participate
Who cannot join
- Patient refusing to participate
- Patient hospitalized for reasons other than allogeneic haematopoietic stem cells
About this study
Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a particular time in the management of patients with malignant hemopathies both for the patient, for his entourage or for the nursing staff. For the patient, the strict protective isolation set up during this period is a source of isolation in the broad sense and is associated with an escape from external events and society. It also constitutes a physical barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even psychological in relations with relatives. Moreover, this period is also difficult because of the possible complications of conditioning (mucositis, transit disorders, fever ...) and allograft itself (graft versus host disease, no transplant, relapse disease…). The patient may be weakened and diminished, which can give a feeling of helplessness and uselessness to the family. Finally, this therapy can have serious physical and psychological consequences for the patient and his entourage (especially in the case of family allograft) who do not always have the possibility to express themselves verbally. Published studies in hematology report depressive, anxious and post-traumatic stress disorders in patients and relatives during allogeneic haematopoietic stem cell transplantation. It is therefore important to reduce these symptoms, particularly those related to the cut-off during hospitalization for allogeneic haematopoietic stem cells.
Over the last decade or so, the logbook has been used in some resuscitation services in intubated patients, with the main objective of filling the "memory gap" mentioned by the intubated patients when they woke up and limiting the trauma associated with this Cut in the world corresponding to the sedation period. For this purpose, the use of a logbook in Hematology, by analogy with what is used in the resuscitation services, could be a means of limiting the psychological complications related to the allograft.
- Conditions
- Allogeneic Disease, Hematopoietic Stem Cell
- Being tested
- Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cellsOther
Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Patient hospitalized for allogeneic haematopoietic stem cells | Other | Not described Receives: Other: Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the effectiveness of the logbook made available to hospitalized patients in hematology to limit the psychological complications related to the allograft.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Jul 2017
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149952
- Sponsor's protocol ID
- PI2016_843_0012
- Acronym
- CABALLO
- Status last verified
- Jun 2026
- First submitted
- 2 May 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility of Setting up a Logbook for Allogeneic Haematopoietic Stem Cell Patients at the University Hospital of Amiens
- ClinicalTrials.gov ID
- NCT03149952
- Acronym / sponsor ID
- CABALLO / PI2016_843_0012
- Conditions
- Allogeneic Disease, Hematopoietic Stem Cell
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 11 May 2017 (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.
Hospitalization for allogeneic haematopoietic stem cell transplantation constitutes a particular time in the management of patients with malignant hemopathies both for the patient, for his entourage or for the nursing staff. For the patient, the strict protective isolation set up during this period is a source of isolation in the broad sense and is associated with an escape from external events and society. It also constitutes a physical barrier (mask, charlotte, surblouse and overshoes worn by caregivers or visitors) and even psychological in relations with relatives. Moreover, this period is also difficult because of the possible complications of conditioning (mucositis, transit disorders, fever ...) and allograft itself (graft versus host disease, no transplant, relapse disease…). The patient may be weakened and diminished, which can give a feeling of helplessness and uselessness to the family. Finally, this therapy can have serious physical and psychological consequences for the patient and his entourage (especially in the case of family allograft) who do not always have the possibility to express themselves verbally. Published studies in hematology report depressive, anxious and post-traumatic stress disorders in patients and relatives during allogeneic haematopoietic stem cell transplantation. It is therefore important to reduce these symptoms, particularly those related to the cut-off during hospitalization for allogeneic haematopoietic stem cells.
Over the last decade or so, the logbook has been used in some resuscitation services in intubated patients, with the main objective of filling the "memory gap" mentioned by the intubated patients when they woke up and limiting the trauma associated with this Cut in the world corresponding to the sedation period. For this purpose, the use of a logbook in Hematology, by analogy with what is used in the resuscitation services, could be a means of limiting the psychological complications related to the allograft.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient hospitalized for allogeneic haematopoietic stem cells | Other | Other: Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major hospitalized patient for allogeneic haematopoietic stem cells
- Patient agreeing to participate
Key exclusion criteria (2 listed)
- Patient refusing to participate
- Patient hospitalized for reasons other than allogeneic haematopoietic stem cells
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 |
|---|---|---|
| Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cellsEvaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells. | Other | Patient hospitalized for allogeneic haematopoietic stem cells |
Primary outcome
Analysis of the effectiveness of the logbook made available to hospitalized patients in hematology to limit the psychological complications related to the allograft.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells in people with Allogeneic Disease and Hematopoietic Stem Cell, run by Centre Hospitalier Universitaire, Amiens.
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 2 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: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Analysis of the effectiveness of the logbook made available to hospitalized patients in hematology to limit the psychological complications related to the allograft. (time frame: 1 year). 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 11 Jun 2026.