Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health: A Multiple-Site Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Parent Caregiver Fatigue as Measured by the Fatigue Scale-14 (FS-14)
研究概览
简要总结
This multicenter randomized controlled trial aims to develop and evaluate two Smart Holistic Health Care Platforms (SHHCPs) for families of children with cancer in Taiwan: the Parent Smart Holistic Health Care Platform (P-SHHCP) for parents and the Child Smart Holistic Health Care Platform (C-SHHCP) for children. Children diagnosed with leukemia or brain tumors and their primary caregivers (parents) will be recruited from pediatric oncology and hematology units at four medical centers in northern Taiwan. The SHHCPs are designed to strengthen communication and connection between families and health care providers and to provide holistic support for physical, psychological, social, and spiritual needs during cancer treatment.The study will evaluate the effects of the P-SHHCP and C-SHHCP on the physical, psychological, social, and spiritual well-being of children with cancer and their parents during treatment.
详细描述
This study is a multicenter randomized controlled trial conducted at four medical centers in northern Taiwan: Tri-Service General Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, and Mackay Memorial Hospital. Children diagnosed with leukemia or brain tumors and their primary caregivers (parents) will be recruited from pediatric oncology and hematology units using convenience sampling.
The study aims to develop and evaluate two Smart Holistic Health Care Platforms (SHHCPs): the Parent Smart Holistic Health Care Platform (P-SHHCP) and the Child Smart Holistic Health Care Platform (C-SHHCP). The platforms are designed to strengthen communication between families and health care providers and to provide holistic support addressing physical, psychological, social, and spiritual needs throughout cancer treatment.
Eligible parent and child participants will complete baseline assessments before the intervention. Participants assigned to the intervention group will receive the SHHCP intervention, while participants assigned to the control group will receive usual care. Outcome measures will be assessed at four time points: baseline (T0), 2 months (T1), 5 months (T2), and 8 months (T3).
For parents, the study will evaluate fatigue, quality of life, anxiety, resilience, post-traumatic growth, parenting self-efficacy, and spiritual well-being. For children, outcomes will include cancer-related fatigue, pediatric quality of life, physical and psychological health, behavioral and emotional outcomes, and spiritual well-being. The primary objective is to determine whether the P-SHHCP and C-SHHCP improve the physical, psychological, social, and spiritual health and well-being of parents and children during cancer treatment compared with usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of a child diagnosed with leukemia or a brain tumor. The child is between 2 and 18 years of age. The parent is the primary caregiver of the child, agrees to participate in the study, and is willing to complete self-administered questionnaires.
- •Able to speak, understand, read, and write Chinese. Has access to the Internet. Has no cognitive impairment. Has not previously participated in another study involving a smart health care platform.
- •Is not taking medications that may affect fatigue, anxiety, mood, or behavior.
- •Diagnosed with leukemia or a brain tumor. Between 7 and 18 years of age. Is not taking medications that may affect fatigue, anxiety, mood, or behavior. Able to communicate in Chinese. Has no cognitive impairment. Able to use a smartphone or tablet independently or with assistance from a caregiver.
- •Will not participate in another smart health care platform study during the study period.
- •Has a stable disease condition and emotional status.
排除标准
- •The child has not been diagnosed with leukemia or a brain tumor. The parent is not the primary caregiver of the child or is unwilling to participate in the study and complete the study questionnaires.
- •Unable to speak, understand, read, or write Chinese. Does not have access to the Internet. Has cognitive impairment. Has previously participated in another study involving a smart health care platform.
- •Is taking medications that may affect fatigue, anxiety, mood, or behavior.
- •Has a psychiatric disorder, such as schizophrenia, depression, or bipolar disorder, or has cognitive impairment or a sleep disorder.
- •Has a congenital disease or congenital anomaly. Has a severe medical condition requiring treatment, such as a severe infection. Has terminal-stage cancer with multiple complications.
研究组 & 干预措施
SHHCP Intervention Group
Participants in the intervention group will receive the Smart Holistic Health Care Platform (SHHCP) in addition to usual care. Parents will receive the Parent Smart Holistic Health Care Platform (P-SHHCP), and children will receive the Child Smart Holistic Health Care Platform (C-SHHCP). The platforms are designed to strengthen communication and connection between families and health care providers and to provide physical, psychological, social, and spiritual support during cancer treatment. Outcomes will be assessed at baseline and at 2, 5, and 8 months.
干预措施: Parent Smart Holistic Health Care Platform (P-SHHCP) (Behavioral)
SHHCP Intervention Group
Participants in the intervention group will receive the Smart Holistic Health Care Platform (SHHCP) in addition to usual care. Parents will receive the Parent Smart Holistic Health Care Platform (P-SHHCP), and children will receive the Child Smart Holistic Health Care Platform (C-SHHCP). The platforms are designed to strengthen communication and connection between families and health care providers and to provide physical, psychological, social, and spiritual support during cancer treatment. Outcomes will be assessed at baseline and at 2, 5, and 8 months.
干预措施: Child Smart Holistic Health Care Platform (C-SHHCP) (Behavioral)
Usual Care Control Group
Participants in the control group will receive usual care without access to the SHHCP intervention during the study period. They will continue to receive routine clinical care and cancer treatment as provided by their health care team. Outcomes will be assessed at the same time points as the intervention group: baseline and at 2, 5, and 8 months.
结局指标
主要结局
Change in Parent Caregiver Fatigue as Measured by the Fatigue Scale-14 (FS-14)
时间窗: Baseline, 2 months, 5 months, and 8 months
Parent caregiver fatigue will be assessed using the 14-item Fatigue Scale-14 (FS-14). The scale consists of two dimensions: physical fatigue (8 items) and mental fatigue (6 items). Each item is scored as 0 or 1. The total score ranges from 0 to 14, with higher scores indicating greater fatigue.
Change in Child Spiritual Well-Being as Measured by the Feeling Good, Living Life (FGLL) Questionnaire
时间窗: Baseline, 2 months, 5 months, and 8 months
Child spiritual well-being will be assessed using the Feeling Good, Living Life (FGLL) questionnaire. The instrument assesses children's ideal spiritual well-being ("Feeling Good") and their lived experience of spiritual well-being ("Living Life"). Items are rated on a 5-point scale from 1 (no) to 5 (yes), with higher scores reflecting higher levels of spiritual well-being.
Change in Child Behavioral and Emotional Problems as Measured by the Child Behavior Checklist (CBCL)
时间窗: Baseline, 2 months, 5 months, and 8 months
Child behavioral and emotional problems will be assessed using the 113-item Child Behavior Checklist (CBCL), a parent-report measure designed for children and adolescents aged 6 to 18 years. Items are rated on a 3-point scale from 0 (absent) to 2 (occurs often), with higher scores indicating greater behavioral and emotional problems.
Change in Parent Caregiver Anxiety as Measured by the Beck Anxiety Inventory (BAI)
时间窗: Baseline, 2 months, 5 months, and 8 months
Parent caregiver anxiety will be assessed using the 21-item Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale from 0 to 3. Higher total scores indicate greater severity of anxiety symptoms.
Change in Parent Spiritual Well-Being as Measured by the Spiritual Well-Being Scale (SWBS)
时间窗: Baseline, 2 months, 5 months, and 8 months
Parent spiritual well-being will be assessed using the 20-item Spiritual Well-Being Scale (SWBS), consisting of religious well-being and existential well-being subscales. Items are rated on a 6-point Likert scale. Total scores range from 20 to 120, with higher scores indicating greater spiritual well-being.
Change in Cancer-Related Fatigue in Children as Measured by the Cancer-Related Fatigue Questionnaire (CRFQ)
时间窗: Baseline, 2 months, 5 months, and 8 months
Cancer-related fatigue in children will be assessed using the 25-item Cancer-Related Fatigue Questionnaire (CRFQ). The questionnaire assesses four domains: daily activities, general fatigue-related issues, sleep difficulties, and mental and emotional status. Each item is rated on a 4-point scale from 1 to 4. Total scores range from 25 to 100, with lower scores indicating greater cancer-related fatigue.
次要结局
- Change in Parent Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)(Baseline, 2 months, 5 months, and 8 months)
- Change in Cancer-Related Parenting Self-Efficacy(Baseline, 2 months, 5 months, and 8 months)
- Change in Parent Caregiver Posttraumatic Growth as Measured by the Posttraumatic Growth Inventory (PTGI)(Baseline, 2 months, 5 months, and 8 months)
- Change in Pediatric Physical and Psychosocial Health as Measured by the PROMIS Pediatric-25(Baseline, 2 months, 5 months, and 8 months)
- Change in Pediatric Health-Related Quality of Life as Measured by the PedsQL 4.0 Generic Core Scales(Baseline, 2 months, 5 months, and 8 months)
- Change in Parent Caregiver Resilience as Measured by the Connor-Davidson Resilience Scale (CD-RISC-25)(Baseline, 2 months, 5 months, and 8 months)
- Change in Cancer-Related Fatigue in Children as Measured by the Cancer-Related Fatigue Questionnaire (CRFQ)(Baseline, 2 months, 5 months, and 8 months)
研究者
Jen-Jiuan Liaw
Professor
National Defense Medical University, Taiwan