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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Children's Hospital
RECRUITING
Taipei
Contact Information
Primary
Jen-Jiuan Liaw, PhD
jiuanliaw@gmail.com
+886-2-87923100
Time Frame
Start Date: 2025-12-30
Estimated Completion Date: 2028-08-30
Participants
Target number of participants: 120
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: National Defense Medical University, Taiwan

This content was sourced from clinicaltrials.gov