Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health

NCT07805096 | Recruiting

• 1 other identifier: B202505032
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia (Both ALL and AML); Brain Tumors

Keywords

Pediatric Cancer; Holistic Care; Quality of Life; Smart Holistic Health Care; Family-Centered Care; Psychosocial Support; Spiritual Well-Being

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline, 2 months, 5 months, and 8 months

• 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.

  Baseline, 2 months, 5 months, and 8 months

• 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.

  Baseline, 2 months, 5 months, and 8 months

• 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.

  Baseline, 2 months, 5 months, and 8 months

• Change in Parent Spiritual Well-Being as Measured by the Spiritual Well-Being Scale (SWBS)

  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.

  Baseline, 2 months, 5 months, and 8 months

• Change in Cancer-Related Fatigue in Children as Measured by the Cancer-Related Fatigue Questionnaire (CRFQ)

  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.

  Baseline, 2 months, 5 months, and 8 months

Secondary Outcomes (7)

• Change in Parent Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)

  Baseline, 2 months, 5 months, and 8 months

• Change in Cancer-Related Parenting Self-Efficacy

  Baseline, 2 months, 5 months, and 8 months

• Change in Parent Caregiver Posttraumatic Growth as Measured by the Posttraumatic Growth Inventory (PTGI)

  Baseline, 2 months, 5 months, and 8 months

• Change in Pediatric Physical and Psychosocial Health as Measured by the PROMIS Pediatric-25

  Baseline, 2 months, 5 months, and 8 months

• Change in Pediatric Health-Related Quality of Life as Measured by the PedsQL 4.0 Generic Core Scales

  Baseline, 2 months, 5 months, and 8 months

Study Arms (2)

SHHCP Intervention Group

EXPERIMENTAL

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.

Behavioral: Parent Smart Holistic Health Care Platform (P-SHHCP); Behavioral: Child Smart Holistic Health Care Platform (C-SHHCP)

Usual Care Control Group

NO INTERVENTION

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.

Interventions

Child Smart Holistic Health Care Platform (C-SHHCP) BEHAVIORAL

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.

SHHCP Intervention Group

Parent Smart Holistic Health Care Platform (P-SHHCP) BEHAVIORAL

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.

SHHCP Intervention Group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Defense Medical University, Taiwan: lead

Study Sites (1)

National Taiwan University Children's Hospital

Taipei, 10041, Taiwan

RECRUITING

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Brain Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jen-Jiuan Liaw, PhD

CONTACT

+886-2-87923100; jiuanliaw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either the SHHCP intervention group or the usual care control group in a parallel-group design. Outcomes will be assessed at baseline and at 2, 5, and 8 months.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-01

Locations

TW (1)