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

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.

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.

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.