Malignant HaemopathyNCT03541330
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
A study testing semi-directive interview in people with Malignant Haemopathy, run by University Hospital, Lille at 1 site in France.
Trial summary
The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Haemopathy
- What is being tested?
- semi-directive interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2018to 1 Apr 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 6 to 12 years old
- Brother or sister of a child:
- O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included
- whose parents are able to understand and sign voluntarily informed consent
- Affiliated to a social security scheme
- Ability to understand and answer questions alone during the semi-structured interview
Who cannot join
- Child under 6 years or over 12 years
- Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment
- Absence of the informed consent of one of the parents and / or the legal representative
- Refusal of participation of the subject
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille
- Conditions
- Malignant Haemopathy
- Being tested
- semi-directive interview
- Keywords
- Siblings, information, malignant haemopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-directive interviewOther
semi-structured interview conducted by a clinical psychologist
| Study group | Role | What they receive |
|---|---|---|
| siblings | Other | Brother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department Receives: Other: semi-directive interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy.
Assessment of the level of satisfaction with the information received. The information will be characterized according to three dimensions: the framework (by whom, with whom, where, when, how) and the content of the information
Measured: 1 year
Secondary outcomes (3)
Explore the representations of the disease in healthy siblings
The representation of the disease is the set of personal beliefs of an individual about the disease. It allows him to make sense of the disease. These data will be analyzed during the semi-structured interview
Measured: 1 year
Evaluate their information and support needs following the announcement of the disease
information and support needs gathered during the semi-structured interview
Measured: 1 year
Identify the possible psychic and social consequences of the disease in these healthy subjects
to identify during the semi-directive interview the elements informing about the social behavior and the psychic state of the subject included, expressed spontaneously by the subject, directly (in the speech, for example "I am sad") or indirectly (by attitude, for example: crying)
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 posted30 May 2018
- Study start22 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: default of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HaemopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva De Berranger, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541330
- Sponsor's protocol ID
- 2016_83
- Other IDs
- 2016-A02091-50
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2017
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.
- ClinicalTrials.gov ID
- NCT03541330
- Acronym / sponsor ID
- 2016_83
- Conditions
- Malignant Haemopathy
- Keywords
- Siblings, information, malignant haemopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: default of inclusion
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 May 2018 (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.
The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| siblings | Other | Other: semi-directive interviewBrother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children from 6 to 12 years old
- Brother or sister of a child:
- O has malignant haemopathy O follow-up in the pediatric hematology department in Lille, O diagnosed from 6 weeks to 1 year before maintenance of the healthy subject included
- whose parents are able to understand and sign voluntarily informed consent
- Affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Child under 6 years or over 12 years
- Subject with a pathology that may interfere with the course of the study, according to the investigator's assessment
- Absence of the informed consent of one of the parents and / or the legal representative
- Refusal of participation of the subject
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 |
|---|---|---|
| semi-directive interviewsemi-structured interview conducted by a clinical psychologist | Other | siblings |
Primary outcome
Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies
Time frame: 1 year
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy. Assessment of the level of satisfaction with the information received. The information will be characterized according to three dimensions: the framework (by whom, with whom, where, when, how) and the content of the information
3 secondary outcomes
Explore the representations of the disease in healthy siblings
Time frame: 1 year
Evaluate their information and support needs following the announcement of the disease
Time frame: 1 year
Identify the possible psychic and social consequences of the disease in these healthy subjects
Time frame: 1 year
Results and safety
The study was stopped early (reason given: default of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Malignant Haemopathy
Recruiting
Proof of Concept to Assess the Feasibility of a Decentralised Pathway Coordinated by the Advanced Practice Nurse for Patients Receiving Oral Treatment for Cancer or Malignant Haemopathy (ACCELER PLATFORM)
Solid Cancer, Haematological Malignancies
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.
Eva De Berranger, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semi-directive interview in people with Malignant Haemopathy, run by University Hospital, Lille 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Dec 2025. 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 was stopped early (reason given: default of inclusion). Results are not available in the source record.
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?
Level of satisfaction and characteristics of information received about the disease by healthy siblings of children with hematological malignancies (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 Dec 2025.