Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06107478 |
| Other study ID # |
ET23000304 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Centre Leon Berard |
| Contact |
Magali GIRODET, PHD |
| Phone |
+33469856070 |
| Email |
magali.girodet[@]lyon.unicancer.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
