Acute Lymphoblastic Leukemia, PediatricMASSAYANCT06107478
Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology Before and After "Magic Massages"
An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Centre Leon Berard.
Trial summary
Rationale: In France, 1,850 cases of cancer are diagnosed in children every year (28% of leukaemia). Despite a cure rate of 83% (all cancers combined), treatment remains a major burden. Changes to the body caused by the disease and its treatment can alter their self-image and the way they relate to their bodies. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Self-report questionnaires (only for parents), Interview (only for parents) and Clinical data collection (only concerning Children)
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jan 2025
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be systematically offered to all parents of a child with ALL who meet the inclusion criteria, at the time of their visit to an investigating center for any treatment, and who have not yet completed the magic massages (MM) training course. As the child's (patient's) clinical data will be collected, he or she will also be considered a participant.
Who may be able to join
- Have ALL and be in the induction phase of treatment (at least one-month post-diagnosis and up to 50 days post-diagnosis, according to the ALL Together 2023 treatment protocol).
- Be 2 to 12 years of age at diagnosis
- Be under the care of one of the study's investigating centers
- Have been informed of the study in a manner appropriate to their abilities and not to have opposed it
- Criteria for non-inclusion of children:
- Not be followed for the duration of the study
- Have refused to take part in the study
- Be deprived of liberty by a court or administrative order
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology: Pre-post "Magic Massages" Study
Rationale: In France, 1,850 cases of cancer are diagnosed in children every year (28% of leukaemia). Despite a cure rate of 83% (all cancers combined), treatment remains a major burden. Changes to the body caused by the disease and its treatment can alter their self-image and the way they relate to their bodies. The massage benefits for children have been highlighted, improving their quality of life (QoL) during treatment. The importance of including parents in the paediatric care process in order to strengthen family ties was also highlighted. Recently, the La Roche-Posay Foundation, in conjunction with a group of experts, developed and rolled out a training course called "Magic Massages" (MM), aimed at parents. The Human and Social Sciences Department of the Léon Bérard Center, in collaboration with the Institute of Paediatric Haematology and Oncology, and with the support of the La Roche Posay Foundation, is conducting a longitudinal multicenter observational study, the main aim of which is to assess parental perceptions of the impact of therapeutic massage on their child's emotional QoL. The secondary objectives of this study are to assess parental perception of the impact of therapeutic massage on their child's QoL and emotional distress (i.e. anxiety and depression), as well as on the quality of the parent-child-caregiver relationship.
Method: In this mixed-method study, 181 parents with a child aged 2 to 12 years treated for acute lymphoblastic leukaemia and diagnosed at least one month previously will be recruited; 161 for the quantitative part, and 20 others will be recruited for the qualitative part. Recruitment will take place nationwide in several oncopaediatric centres. Thus, in the quantitative part of the study, parent participants will complete self-reported measures of their child's QoL, anxiety and depression, as well as parent-child and parent-caregiver relationships. Data will be collected before training (T0); 3 weeks (T1) and 6 weeks after MM training (T2). Concerning the qualitative part, semi-directive interviews will be conducted with participants at T1.
Expected results: The implementation of MM would lead to an improvement in QoL, as well as a reduction in anxiety and depression perceived by parents in their child. An increase in the perceived quality of parent-child-caregiver relationships is also expected. In the long term, large-scale deployment of MM could be envisaged, including in other diseases.
Read the detailed description
Study Type:
Human and social sciences research (NRIPH), observational, mixed (i.e., quantitative and qualitative), longitudinal and multicenter. The study will involve three measurement phases:
T0: before training in "Magic Massages" (MM) T1: 3 weeks after MM training T2: 6 weeks after MM training
Principal aim:
To describe and compare parental perception of the quality of life/psychosocial health of their child with acute lymphoblastic leukaemia (ALL) before MM training (T0) and 3 weeks after MM training (T1).
Secondary aims:
- To describe parental perception of the quality of life of their child with ALL before MM training (T0), 3 weeks after MM training (T1) and 6 weeks after MM training (T2).
- To describe parental perception of emotional distress (anxiety/depression) in their child with ALL before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Describe parental perception of the relationship with their child before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Describe parental perception of their relationship with the caregiver before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Qualitatively collect parents' perceptions of their child's overall quality of life, their relationship with their child and the dynamic established with the healthcare team 3 weeks after MM training (T1).
Study Population:
The study will be systematically offered to all parents of a child with ALL who meet the inclusion criteria, at the time of their visit to an investigating center for any treatment, and who have not yet completed the MM training course.
As the child's (patient's) clinical data will be collected, he or she will also be considered a participant.
Study conduct:
The study will be systematically proposed via the team in charge to all parents of a sick child who meet the inclusion and non-inclusion criteria.
The proposal to participate will be made during the induction phase of the patient's treatment, at the investigating center. At this point, participants will be provided with an information leaflet tailored to the type of study (quantitative or qualitative) and the participant's status (parent or child). A reasonable period of reflection will be allowed.
- At the Centre Léon Bérard, participants will be offered either the qualitative study or the quantitative study. Participants in the qualitative part must not have taken part in the quantitative part, in order to avoid bias due to contamination of responses between the two parts.
- In the other investigating centers, the quantitative study will be offered exclusively to all potential participants.
After obtaining the participants' non-opposition, the study team will schedule the MM training session for the first day of the patient's first phase of treatment consolidation (D1).
In all centers, parents will be trained in MM by a member of the investigating center's healthcare team. This training will be given on a one-to-one basis and will last approximately 30 minutes. The trainer will show the parents how to use the MM kit with their child, which they will be able to take home after the training.
Quantitative part (all investigating centers):
When they come to the various measurement points (T0, T1 and T2), participants (parents) will be asked to fill in self-questionnaires, either electronically or on paper. If they are unable to come to the center at T1 and/or T2, they will be offered the option of completing the self-questionnaires online. These can also be sent by e-mail or postal mail and received by the same means if necessary.
Clinical data will be collected at T0.
Qualitative part (exclusively at CLB):
Participants (parents) in the qualitative part of the study will be asked to complete a self-administered questionnaire on socio-demographic data when they come to the center at T0. Clinical data will also be collected at T0. At T1, an interview will be organized with a researcher dedicated to the study. Qualitative interviews will preferably take place face-to-face, although videoconferencing may be used in certain circumstances.
Expected results:
The use of MM is thought to lead to an improvement in quality of life, as well as a reduction in anxiety and depression perceived by parents in their sick child. An increase in the quality of the parent-child-caregiver relationship is also expected.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Self-report questionnaires (only for parents), Interview (only for parents), Clinical data collection (only concerning Children)
- Keywords
- Oncopeadiatrics, Quality of life, Anxiety, Depression, Parental perception, Parent-child-caregiver relationship, Massages
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report questionnaires (only for parents)Other
Quantitative part (all investigating centers): When they come to the various timepoints (T0, T1, T2), participants will be asked to fill in self-questionnaires, either electronically or on paper. If they are unable to come to the center at T1 and/or T2, they will be offered the option of completing the self-questionnaires online. These can also be sent by e-mail or postal mail and received by the same means if necessary.
The tools:
- Quality of life: Pediatric Quality of Life Inventory
- Anxiety: Edmonton Symptom Assessment System; Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
- Depression: Edmonton Symptom Assessment System; PROMIS depression scale
- Parent-child relationship: Ad hoc questionnaire
- Parent-caregiver relationship: Enabling Practices Scale Socio-demographic data on parents and children, data relating to supportive care will be collected at inclusion. Massage habits will be collected at T1 and T2.
Interview (only for parents)Other
Qualitative part (exclusively at CLB):
Participants (parents) in the qualitative part of the study will be asked to complete a self-administered questionnaire on socio-demographic data when they come to the center at T0. Clinical data will also be collected at T0. At T1, an interview will be organized with a researcher dedicated to the study. Qualitative interviews will preferably take place face-to-face, although videoconferencing may be used in certain circumstances.
Clinical data collection (only concerning Children)Other
The children's medical data (patients) will be collected in a Case Report Form (CRF; e.g. type of cancer, date of diagnosis, anti-cancer treatments received, symptoms) at T0.
| Study group | Role | What they receive |
|---|---|---|
| Children ALL, 2-12 years old | Children with acute lymphoblastic leukemia (ALL) and in the induction phase of its treatment (at least one month post-diagnosis and up to 50 days post-diagnosis, i.e. until the first day of consolidation). Receives: Other: Clinical data collection (only concerning Children) | |
| Parents of children ALL | Parents of a patient with acute lymphoblastic leukemia (ALL) being in the induction phase of his treatment (at least one month post-diagnosis and up to 50 days post-diagnosis, i.e. until the first day of consolidation), 2 to 12 years of age at diagnosis and managed by a participating centre. Receives: Other: Self-report questionnaires (only for parents); Other: Interview (only for parents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial health quality of life score at T0 and T1
The emotional quality of life score will be calculated based on the psychosocial health dimension of PedsQL (Pediatric Quality of Life Inventory; 5 items).
Measured: Timepoint 0 (T0) and Timepoint 1 (T1)
Secondary outcomes (5)
Scores for different quality of life dimensions at T0, T1 and T2
The parental perception of the quality of life relative to the health of their child will be measured thanks to the quality of life scores of PedsQL: physical, emotional, social, school, and total score.
Measured: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Anxiety and depression scores at T0, T1 and T2
The parental perception of the emotional distress (anxiety and depression) of the child will be measured through the scores of anxiety and depression, from the PROMIS self-questionnaires and a numerical scale from 0 to 10.
Measured: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Responses to items concerning the parent-child relationship at T0, T1 and T2
The parental perception of the relationship with their child will be described on the basis of an ad hoc self-questionnaire built specifically for the MASSAYA study.
Measured: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Parent/caregiver relationship score at T0, T1 and T2
Parental perception of the relationship with the caregiver will be measured using a score from the EPS7 self-questionnaire.
Measured: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Qualitative collection of parents' perceptions of their child's overall quality of life, their relationship with their child and with the healthcare team at T1
The parental perception of the overall QoL of their child and the parent-child-caregiver relationships will be collected qualitatively and described through a semi-directive interview at T1.
Measured: Timepoint 1 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Hématologie et d'Oncologie Pédiatrique, Fondation La Roche Posay
- Responsible party
- Sponsor
- Investigators
- Véronique CHRISTOPHE, PR, Study director, Centre Leon BerardAmélie ANOTA, PHD, Study director, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107478
- Sponsor's protocol ID
- ET23000304
- Acronym
- MASSAYA
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 30 Oct 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology: Pre-post "Magic Massages" Study
- ClinicalTrials.gov ID
- NCT06107478
- Acronym / sponsor ID
- MASSAYA / ET23000304
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- Oncopeadiatrics, Quality of life, Anxiety, Depression, Parental perception, Parent-child-caregiver relationship, Massages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Institut d'Hématologie et d'Oncologie Pédiatrique, Fondation La Roche Posay
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 30 Oct 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.
Rationale: In France, 1,850 cases of cancer are diagnosed in children every year (28% of leukaemia). Despite a cure rate of 83% (all cancers combined), treatment remains a major burden. Changes to the body caused by the disease and its treatment can alter their self-image and the way they relate to their bodies. The massage benefits for children have been highlighted, improving their quality of life (QoL) during treatment. The importance of including parents in the paediatric care process in order to strengthen family ties was also highlighted. Recently, the La Roche-Posay Foundation, in conjunction with a group of experts, developed and rolled out a training course called "Magic Massages" (MM), aimed at parents. The Human and Social Sciences Department of the Léon Bérard Center, in collaboration with the Institute of Paediatric Haematology and Oncology, and with the support of the La Roche Posay Foundation, is conducting a longitudinal multicenter observational study, the main aim of which is to assess parental perceptions of the impact of therapeutic massage on their child's emotional QoL. The secondary objectives of this study are to assess parental perception of the impact of therapeutic massage on their child's QoL and emotional distress (i.e. anxiety and depression), as well as on the quality of the parent-child-caregiver relationship.
Method: In this mixed-method study, 181 parents with a child aged 2 to 12 years treated for acute lymphoblastic leukaemia and diagnosed at least one month previously will be recruited; 161 for the quantitative part, and 20 others will be recruited for the qualitative part. Recruitment will take place nationwide in several oncopaediatric centres. Thus, in the quantitative part of the study, parent participants will complete self-reported measures of their child's QoL, anxiety and depression, as well as parent-child and parent-caregiver relationships. Data will be collected before training (T0); 3 weeks (T1) and 6 weeks after MM training (T2). Concerning the qualitative part, semi-directive interviews will be conducted with participants at T1.
Expected results: The implementation of MM would lead to an improvement in QoL, as well as a reduction in anxiety and depression perceived by parents in their child. An increase in the perceived quality of parent-child-caregiver relationships is also expected. In the long term, large-scale deployment of MM could be envisaged, including in other diseases.
Detailed description
Study Type:
Human and social sciences research (NRIPH), observational, mixed (i.e., quantitative and qualitative), longitudinal and multicenter. The study will involve three measurement phases:
T0: before training in "Magic Massages" (MM) T1: 3 weeks after MM training T2: 6 weeks after MM training
Principal aim:
To describe and compare parental perception of the quality of life/psychosocial health of their child with acute lymphoblastic leukaemia (ALL) before MM training (T0) and 3 weeks after MM training (T1).
Secondary aims:
- To describe parental perception of the quality of life of their child with ALL before MM training (T0), 3 weeks after MM training (T1) and 6 weeks after MM training (T2).
- To describe parental perception of emotional distress (anxiety/depression) in their child with ALL before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Describe parental perception of the relationship with their child before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Describe parental perception of their relationship with the caregiver before MM training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
- Qualitatively collect parents' perceptions of their child's overall quality of life, their relationship with their child and the dynamic established with the healthcare team 3 weeks after MM training (T1).
Study Population:
The study will be systematically offered to all parents of a child with ALL who meet the inclusion criteria, at the time of their visit to an investigating center for any treatment, and who have not yet completed the MM training course.
As the child's (patient's) clinical data will be collected, he or she will also be considered a participant.
Study conduct:
The study will be systematically proposed via the team in charge to all parents of a sick child who meet the inclusion and non-inclusion criteria.
The proposal to participate will be made during the induction phase of the patient's treatment, at the investigating center. At this point, participants will be provided with an information leaflet tailored to the type of study (quantitative or qualitative) and the participant's status (parent or child). A reasonable period of reflection will be allowed.
- At the Centre Léon Bérard, participants will be offered either the qualitative study or the quantitative study. Participants in the qualitative part must not have taken part in the quantitative part, in order to avoid bias due to contamination of responses between the two parts.
- In the other investigating centers, the quantitative study will be offered exclusively to all potential participants.
After obtaining the participants' non-opposition, the study team will schedule the MM training session for the first day of the patient's first phase of treatment consolidation (D1).
In all centers, parents will be trained in MM by a member of the investigating center's healthcare team. This training will be given on a one-to-one basis and will last approximately 30 minutes. The trainer will show the parents how to use the MM kit with their child, which they will be able to take home after the training.
Quantitative part (all investigating centers):
When they come to the various measurement points (T0, T1 and T2), participants (parents) will be asked to fill in self-questionnaires, either electronically or on paper. If they are unable to come to the center at T1 and/or T2, they will be offered the option of completing the self-questionnaires online. These can also be sent by e-mail or postal mail and received by the same means if necessary.
Clinical data will be collected at T0.
Qualitative part (exclusively at CLB):
Participants (parents) in the qualitative part of the study will be asked to complete a self-administered questionnaire on socio-demographic data when they come to the center at T0. Clinical data will also be collected at T0. At T1, an interview will be organized with a researcher dedicated to the study. Qualitative interviews will preferably take place face-to-face, although videoconferencing may be used in certain circumstances.
Expected results:
The use of MM is thought to lead to an improvement in quality of life, as well as a reduction in anxiety and depression perceived by parents in their sick child. An increase in the quality of the parent-child-caregiver relationship is also expected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children ALL, 2-12 years old | – | Other: Clinical data collection (only concerning Children)Children with acute lymphoblastic leukemia (ALL) and in the induction phase of its treatment (at least one month post-diagnosis and up to 50 days post-diagnosis, i.e. until the first day of consolidation). |
| Parents of children ALL | – | Other: Self-report questionnaires (only for parents), Other: Interview (only for parents)Parents of a patient with acute lymphoblastic leukemia (ALL) being in the induction phase of his treatment (at least one month post-diagnosis and up to 50 days post-diagnosis, i.e. until the first day of consolidation), 2 to 12 years of age at diagnosis and managed by a participating centre. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be systematically offered to all parents of a child with ALL who meet the inclusion criteria, at the time of their visit to an investigating center for any treatment, and who have not yet completed the magic massages (MM) training course. As the child's (patient's) clinical data will be collected, he or she will also be considered a participant.
Key inclusion criteria (8 listed)
- Have ALL and be in the induction phase of treatment (at least one-month post-diagnosis and up to 50 days post-diagnosis, according to the ALL Together 2023 treatment protocol).
- Be 2 to 12 years of age at diagnosis
- Be under the care of one of the study's investigating centers
- Have been informed of the study in a manner appropriate to their abilities and not to have opposed it
- Not be followed for the duration of the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-report questionnaires (only for parents)Quantitative part (all investigating centers): When they come to the various timepoints (T0, T1, T2), participants will be asked to fill in self-questionnaires, either electronically or on paper. If they are unable to come to the center at T1 and/or T2, they will be offered the option of completing the self-questionnaires online. These can also be sent by e-mail or postal mail and received by the same means if necessary. The tools: * Quality of life: Pediatric Quality of Life Inventory * Anxiety: Edmonton Symptom Assessment System; Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale * Depression: Edmonton Symptom Assessment System; PROMIS depression scale * Parent-child relationship: Ad hoc questionnaire * Parent-caregiver relationship: Enabling Practices Scale Socio-demographic data on parents and children, data relating to supportive care will be collected at inclusion. Massage habits will be collected at T1 and T2. | Other | Parents of children ALL |
| Interview (only for parents)Qualitative part (exclusively at CLB): Participants (parents) in the qualitative part of the study will be asked to complete a self-administered questionnaire on socio-demographic data when they come to the center at T0. Clinical data will also be collected at T0. At T1, an interview will be organized with a researcher dedicated to the study. Qualitative interviews will preferably take place face-to-face, although videoconferencing may be used in certain circumstances. | Other | Parents of children ALL |
| Clinical data collection (only concerning Children)The children's medical data (patients) will be collected in a Case Report Form (CRF; e.g. type of cancer, date of diagnosis, anti-cancer treatments received, symptoms) at T0. | Other | Children ALL, 2-12 years old |
Primary outcome
Psychosocial health quality of life score at T0 and T1
Time frame: Timepoint 0 (T0) and Timepoint 1 (T1)
The emotional quality of life score will be calculated based on the psychosocial health dimension of PedsQL (Pediatric Quality of Life Inventory; 5 items).
5 secondary outcomes
Scores for different quality of life dimensions at T0, T1 and T2
Time frame: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Anxiety and depression scores at T0, T1 and T2
Time frame: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Responses to items concerning the parent-child relationship at T0, T1 and T2
Time frame: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Parent/caregiver relationship score at T0, T1 and T2
Time frame: Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)
Qualitative collection of parents' perceptions of their child's overall quality of life, their relationship with their child and with the healthcare team at T1
Time frame: Timepoint 1 (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
Véronique CHRISTOPHE, PR study director
Centre Leon Berard
Amélie ANOTA, PHD study director
Centre Leon Berard
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Centre Leon Berard.
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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali GIRODET, PHD (+33469856070, magali.girodet@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial health quality of life score at T0 and T1 (time frame: Timepoint 0 (T0) and Timepoint 1 (T1)). 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 30 Oct 2023.