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NCT Number: NCT07805096

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

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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Key information

Conditions

Leukemia (Both ALL and AML) Brain Diseases Brain Neoplasms Brain Tumors Central Nervous System Diseases Central Nervous System Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Children's Hospital

Taipei, 10041, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Parent Caregiver Fatigue as Measured by the Fatigue Scale-14 (FS-14)

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

  2. Change in Child Spiritual Well-Being as Measured by the Feeling Good, Living Life (FGLL) Questionnaire

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

  3. Change in Child Behavioral and Emotional Problems as Measured by the Child Behavior Checklist (CBCL)

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

  4. Change in Parent Caregiver Anxiety as Measured by the Beck Anxiety Inventory (BAI)

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

Secondary outcomes

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

  2. Change in Cancer-Related Parenting Self-Efficacy

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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.

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    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).

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    Pediatric health-related quality of life will be assessed using the 23-item PedsQL 4.0 Generic Core Scales. The scale assesses four domains: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Items are rated on a 5-point response scale from 0 (never a problem) to 4 (almost always a problem). Higher scores indicate better health-related quality of life.

  6. Change in Parent Caregiver Resilience as Measured by the Connor-Davidson Resilience Scale (CD-RISC-25)

    Time frame: Baseline, 2 months, 5 months, and 8 months

    Parent caregiver resilience will be assessed using the 25-item Connor-Davidson Resilience Scale (CD-RISC-25). Each item is rated on a 5-point Likert scale from 0 to 4. Total scores range from 0 to 100, with higher scores indicating greater resilience.

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

    Time frame: Baseline, 2 months, 5 months, and 8 months

    Cancer-related fatigue in children will be assessed using the 25-item Cancer-Related Fatigue Questionnaire (CRFQ). The questionnaire assesses 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 fatigue.

Study contacts

Contact information is provided by the study sponsor or research team.

Jen-Jiuan Liaw, PhD

CONTACT

[email protected]

+886-2-87923100

Sponsors and collaborators

Lead sponsor

National Defense Medical University, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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