Recruiting
Not applicable
Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health
Condition(s) studied
Leukemia (Both ALL and AML)Brain Tumors
Investigational drug(s) / intervention(s)
Parent Smart Holistic Health Care Platform (P-SHHCP)Child Smart Holistic Health Care Platform (C-SHHCP)
Parent Smart Holistic Health Care Platform (P-SHHCP): The Parent Smart Holistic Health Care Platform (P-SHHCP) is a digital supportive care intervention designed for parents who are the primary caregivers of children with cancer. The platform aims to strengthen communication and connection between parents and health care providers and to provide holistic support addressing physical, psychological, social, and spiritual needs during the child's cancer treatment.
Child Smart Holistic Health Care Platform (C-SHHCP): The Child Smart Holistic Health Care Platform (C-SHHCP) is a digital supportive care intervention designed for children with leukemia or brain tumors undergoing cancer treatment. The platform aims to strengthen communication and connection between children, their families, and health care providers and to provide holistic support addressing physical, psychological, social, and spiritual needs during cancer treatment.
Study summary
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.
Eligibility
Inclusion Criteria:
Parents:
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.
Children:
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.
Exclusion Criteria:
Parents:
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.
Children:
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.
Primary outcome measure(s)
- Change in Parent Caregiver Fatigue as Measured by the Fatigue Scale-14 (FS-14) — 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 — 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) — 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) — 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) — 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) — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| National Taiwan University Children's Hospital |
Taipei |
Taiwan |
Recruiting |
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