Clinical trial · Interventional
Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Leukemia (Both ALL and AML) | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Child Smart Holistic Health Care Platform (C-SHHCP) | Behavioral | — | UNRESOLVED |
| Parent Smart Holistic Health Care Platform (P-SHHCP) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHHCP Intervention Group
- description
- 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.
- interventionNames
- Behavioral: Parent Smart Holistic Health Care Platform (P-SHHCP)
- Behavioral: Child Smart Holistic Health Care Platform (C-SHHCP)
- type
- NO_INTERVENTION
- label
- Usual Care Control Group
- description
- 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.
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available