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.
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Parent Smart Holistic Health Care Platform (P-SHHCP)
BehavioralThe 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)
BehavioralThe 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.
Change in Parent Caregiver Fatigue as Measured by the Fatigue Scale-14 (FS-14)
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
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)
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)
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 Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Parent caregiver quality of life will be assessed using the 35-item Caregiver Quality of Life Index-Cancer (CQOLC). Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). The scale assesses burden, disruptiveness, positive adaptation, and financial concerns. Total scores range from 0 to 140, with higher scores indicating better quality of life.
Change in Cancer-Related Parenting Self-Efficacy
Cancer-related parenting self-efficacy will be assessed using a 24-item self-report scale designed to evaluate parents' confidence in performing parenting tasks relevant to caring for a child with cancer. Items are rated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree), with higher scores indicating greater parenting self-efficacy.
Change in Parent Caregiver Posttraumatic Growth as Measured by the Posttraumatic Growth Inventory (PTGI)
Posttraumatic growth will be assessed using the 21-item Posttraumatic Growth Inventory (PTGI). Items are rated on a 6-point scale from 0 to 5. The scale assesses positive changes related to new possibilities, relationships with others, personal strength, spiritual growth, and appreciation of life. Higher scores indicate greater posttraumatic growth.
Change in Pediatric Physical and Psychosocial Health as Measured by the PROMIS Pediatric-25
Pediatric physical and psychosocial health will be assessed using the Patient-Reported Outcomes Measurement Information System Pediatric-25 (PROMIS Pediatric-25). The instrument assesses six domains: physical function, anxiety, depressive symptoms, fatigue, peer relationships, and pain interference. Each domain contains four items rated on a 5-point scale. The instrument also includes a single-item Numeric Pain Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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