Trial Title:
Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology Before and After "Magic Massages"
NCT ID:
NCT06107478
Condition:
Acute Lymphoblastic Leukemia, Pediatric
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
Oncopeadiatrics
Quality of life
Anxiety
Depression
Parental perception
Parent-child-caregiver relationship
Massages
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Self-report questionnaires (only for parents)
Description:
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.
Arm group label:
Parents of children ALL
Intervention type:
Other
Intervention name:
Interview (only for parents)
Description:
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.
Arm group label:
Parents of children ALL
Intervention type:
Other
Intervention name:
Clinical data collection (only concerning Children)
Description:
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.
Arm group label:
Children ALL, 2-12 years old
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. 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:
1. 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).
2. 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).
3. Describe parental perception of the relationship with their child before MM training
(T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
4. Describe parental perception of their relationship with the caregiver before MM
training (T0), then 3 weeks (T1) and 6 weeks after MM training (T2).
5. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Criteria for including parents :
- Be the parent of a patient with acute lymphoblastic leukaemia (ALL) 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), aged between
2 and 12 years at diagnosis and under the care of a study investigating center.
- Have agreed to undergo training in the Magic Massage technique at the time of the
study and at one of the study's investigating centers
- Be able to understand, speak, read and write French
- Have been informed of the study and not to have objected
Criteria for not including parents:
- Have refused to take part in the "Magic Massages" training during the study or have
already done so prior to inclusion.
- Have refused or to be incapable of making an informed objection
- Be the 2nd parent of a patient with ALL for whom a 1er parent is already included in
the study.
- Be deprived of liberty by a court or administrative order
Inclusion criteria for children
- 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
Gender:
All
Minimum age:
2 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
October 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Collaborator:
Agency:
Institut d'Hématologie et d'Oncologie Pédiatrique
Agency class:
Other
Collaborator:
Agency:
Fondation La Roche Posay
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06107478
