Parental Perception of Their Child's Emotional Quality of Life in Paediatric Oncology: Pre-post "Magic Massages" Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 181
- 主要终点
- Psychosocial health quality of life score at T0 and T1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Psychosocial health quality of life score at T0 and T1
时间窗: Timepoint 0 (T0) and Timepoint 1 (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).
次要结局
- 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))
- 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))
- Responses to items concerning the parent-child relationship at T0, T1 and T2(Timepoint 0 (T0), Timepoint 1 (T1) and Timepoint 2 (T2))
