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Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology Before and After "Magic Massages"
Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology Before and After "Magic Massages"

NCT06107478

UnknownN/A

Sponsor: Centre Leon Berard

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Interventions: Self-report questionnaires (only for parents), Interview (only for parents), Clinical data collection (only concerning Children)

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.

Eligibility overview

Sex: ALL

Age: 2 Years to

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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