Hematopoietic/Lymphoid CancerJACintHENCT04172818
Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
A study testing quality of life questionnaire in people with Hematopoietic/Lymphoid Cancer and Psychological Disorder, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer, Psychological Disorder
- What is being tested?
- quality of life questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 21 Mar 2023
- 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
- patient age > 18 years
- patient hospitalized for an hematopoietic allogenic stem cell transplantation
- patient agreeing to participate
Who cannot join
- patient not hospitalized for an hematopoietic allogenic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.
- Being tested
- quality of life questionnaire
- Keywords
- allogenic hematopoietic stem cell transplantation, diary, psychological disorders
- Medical subject headings
- Hematologic Neoplasms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireBehavioural
Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diary | Experimental | Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives. Receives: Behavioral: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 0
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at 30 days after transplantation
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 100 after transplantation
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: 6 months after transplantation
Measure of diary impact on patient quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: a year after transplantation
Secondary outcomes (12)
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 0
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at 30 days after transplantation
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 100 after transplantation
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: 6 months after transplantation
Measure of diary impact on health care team satisfaction
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: a year after transplantation
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 0
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at 30 days after transplantation
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: at day 100 after transplantation
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: 6 months after transplantation
Measure of diary impact on patient relative quality of life
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measured: a year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Nov 2019
- Primary completion1 May 2021
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Lebon, MD, Principal investigator, CHU AmiensMarie Beaumont, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172818
- Sponsor's protocol ID
- PI2019_843_0005
- Acronym
- JACintHE
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
- ClinicalTrials.gov ID
- NCT04172818
- Acronym / sponsor ID
- JACintHE / PI2019_843_0005
- Keywords
- allogenic hematopoietic stem cell transplantation, diary, psychological disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 21 Nov 2019 (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.
Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diary | Experimental | Behavioral: quality of life questionnaireEvaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient age > 18 years
- patient hospitalized for an hematopoietic allogenic stem cell transplantation
- patient agreeing to participate
Key exclusion criteria (1 listed)
- patient not hospitalized for an hematopoietic allogenic stem cell transplantation
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 |
|---|---|---|
| quality of life questionnaireSince 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated. | Behavioural | Patients with diary |
Primary outcome
Measure of diary impact on patient quality of life
Time frame: at day 0
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measure of diary impact on patient quality of life
Time frame: through the end of hospitalisation, an average of 3 weeks
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measure of diary impact on patient quality of life
Time frame: at 30 days after transplantation
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measure of diary impact on patient quality of life
Time frame: at day 100 after transplantation
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measure of diary impact on patient quality of life
Time frame: 6 months after transplantation
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Measure of diary impact on patient quality of life
Time frame: a year after transplantation
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
12 secondary outcomes
Measure of diary impact on health care team satisfaction
Time frame: at day 0
Measure of diary impact on health care team satisfaction
Time frame: through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on health care team satisfaction
Time frame: at 30 days after transplantation
Measure of diary impact on health care team satisfaction
Time frame: at day 100 after transplantation
Measure of diary impact on health care team satisfaction
Time frame: 6 months after transplantation
Measure of diary impact on health care team satisfaction
Time frame: a year after transplantation
Measure of diary impact on patient relative quality of life
Time frame: at day 0
Measure of diary impact on patient relative quality of life
Time frame: through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on patient relative quality of life
Time frame: at 30 days after transplantation
Measure of diary impact on patient relative quality of life
Time frame: at day 100 after transplantation
Measure of diary impact on patient relative quality of life
Time frame: 6 months after transplantation
Measure of diary impact on patient relative quality of life
Time frame: a year after transplantation
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 22 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Delphine Lebon, MD principal investigator
CHU Amiens
Marie Beaumont, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life questionnaire in people with Hematopoietic/Lymphoid Cancer and Psychological Disorder, run by Centre Hospitalier Universitaire, Amiens 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 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 22 Mar 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?
Measure of diary impact on patient quality of life (time frame: at day 0). The study lists 6 primary outcomes in all. 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 22 Mar 2023.