Digital Technology for Parents in Pediatric Oncology: Development and Implementation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Parental resources (created for the needs of the study)
研究概览
简要总结
This study aims to develop a mobile App (named "TICOP") for parents of a childhood cancer survivor and an E-Platform for health professionals which work in pediatric oncology area.
The core objective is to evaluate the effects of these two digital tools (mobile app and platform) in the detection and prevention among parents of a childhood cancer survivor.
详细描述
Parents of a childhood cancer survivor face ongoing social, and psychological challenges that may result in enduring illness and caregiving related distress and vulnerabilities. It has been described namely: post posttraumatic stress symptoms [PTSS], lingering worries, anxiety and depression. While strategies and interventions to minimize the child's distress have become part of comprehensive medical care in paediatrics, it also becomes urgent to develop research into parents of a childhood cancer survivor in order to: [1] train the medical staff to identify the serious issue of parental distress ; [2] detect other markers of vulnerabilities (e.g. pessimism, anxiety trait) and [3] provide them with a personalized psychological intervention. This would allow vigilance of the medical staff in detecting parents' distress and could defuse their descent into a vicious circle of psychosocial difficulties.
Up to now, empirical findings suggest the importance to develop a screening tool for parents of a CCS in order to detect any parent who presents several difficulties and to propose personal intervention. To the investigator's knowledge, there is no tool to detect and prevent psychological distress among parents of a childhood cancer survivor.
The TICOP mobile app consists of seven axis of evaluation and detection for parents of a childhood cancer survivor:
Parent moves the cursor by analogy on their mobile phone (as a visual anagogic scale) four times per year (baseline; month 4; month 8 and month 12).
Axis 1: sociodemographic (e.g. gender, marital status) (14 items) Axis 2: psychosomatic symptoms (insomnia, migraine) (16 items) Axis 3: psychological symptoms (e.g. depression, anxiety) (13 items) Axis 4: parental needs (e.g. social support, information) (9 items) Axis 5: parental resources (e.g. emotional support) (8 items) Axis 6: parental risk factors (e.g. anxiety, intolerant of uncertainty) (5 items) Axis 7: parental protective factors (e.g. optimistic,extraverted) (6 items)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of a childhood cancer survivor (mother and father)
- •Child who had been diagnosed in remission since 1 years until 10 years (without relapse)
- •Neoadjuvant chemotherapy during treatments
- •Fluency in French speaking
- •No previous evidence of mental illness.
排除标准
- •Diagnosis of cancer treated only by surgery or radiotherapy (with no adjuvant chemotherapy)
- •Benign tumor
- •Child has a relapse or died
- •Non-French-speaking parents
- •previous evidence of mental illness.
结局指标
主要结局
Parental resources (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
8 items ranged between 0% at 100% \[Visual Analog Scale\]
Parental risk factors (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
5 paired-items ranged between 0% at 100% \[Visual Analog Scale\] Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
Sociodemographic questionnaire (parents of a childhood cancer survivor) (created for the needs of the study)
时间窗: Baseline
14 items (multiple-choice response)
Psychological symptoms (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
13 items ranged between 0% at 100% \[Visual Analog Scale\] Scale range : 0 = rarely; 1 = occasionally ; 2 = often; 3 = mostly Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
Parental needs (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
9 items ranged between 0% at 100% \[Visual Analog Scale\]
Parental protective factors (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
6 paired-items ranged between 0% at 100% \[Visual Analog Scale\] Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
Psychosomatic symptoms (created for the needs of the study)
时间窗: Measure assessing change between four time points (change from Baseline at 4 months, 8 months and 12 months)
16 items ranged between 0% at 100% \[Visual Analog Scale\] Scale range : 0 = rarely; 1 = occasionally ; 2 = often; 3 = mostly Note. Results are significant when the score is above 25% for one single item with at least two occurrences over time period.
次要结局
未报告次要终点
研究者
Vander Haegen Marie
Doctor of Psychology (Ph.D) (Uliège)
University of Liege