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

NCT06107478 | Unknown

• 1 other identifier: ET23000304
• Study Type: observational
• Target: 181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Oncopeadiatrics; Quality of life; Anxiety; Depression; Parental perception; Parent-child-caregiver relationship; Massages

Outcome Measures

Primary Outcomes (1)

• 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).

  Timepoint 0 (T0) and Timepoint 1 (T1)

Secondary Outcomes (5)

• Scores for different quality of life dimensions at T0, T1 and T2

  Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)

• Anxiety and depression scores at T0, T1 and T2

  Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)

• Responses to items concerning the parent-child relationship at T0, T1 and T2

  Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2)

• Parent/caregiver relationship score at T0, T1 and T2

  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

  Timepoint 1 (T1)

Study Arms (2)

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).

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.

Other: Self-report questionnaires (only for parents); Other: Interview (only for parents)

Interventions

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.

Parents of children ALL

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.

Parents of children ALL

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.

Children ALL, 2-12 years old

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• Have refused to take part in the study
• Be deprived of liberty by a court or administrative order

Sponsors & Collaborators

• Centre Leon Berard: lead
• Institut d'Hématologie et d'Oncologie Pédiatrique: collaborator
• Fondation La Roche Posay: collaborator

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anxiety Disorders; Depression

Interventions

Single Person; Interviews as Topic

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Véronique CHRISTOPHE, PR

  Centre Leon Berard

  STUDY DIRECTOR

• Amélie ANOTA, PHD

  Centre Leon Berard

  STUDY DIRECTOR

Central Study Contacts

Magali GIRODET, PHD

CONTACT

+33469856070; magali.girodet@lyon.unicancer.fr

Margaux BOTTICHIO

CONTACT

+33426556756; margaux.bottichio@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 30, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share