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

NCT ID: NCT06107478

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-01-31

Brief 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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Clinical data collection (only concerning Children)

Intervention Type: 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.

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.

Self-report questionnaires (only for parents)

Intervention Type: 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)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut d'Hématologie et d'Oncologie Pédiatrique

UNKNOWN

Sponsor Role: collaborator

Fondation La Roche Posay

UNKNOWN

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique CHRISTOPHE, PR

Role: STUDY_DIRECTOR

Centre Leon Berard

Amélie ANOTA, PHD

Role: STUDY_DIRECTOR

Centre Leon Berard

Central Contacts

Magali GIRODET, PHD

Role: CONTACT

magali.girodet@lyon.unicancer.fr

+33469856070

Margaux BOTTICHIO

Role: CONTACT

margaux.bottichio@lyon.unicancer.fr

+33426556756

Other Identifiers

ET23000304

Identifier Type: -

Identifier Source: org_study_id