Leukemia (Both ALL and AML)NCT07805096
Efficacy of a Smart Holistic Health Care Platform Intervention on Cancer Children and Parents' Bio-Psycho-Social and Spiritual Health
A study testing Parent Smart Holistic Health Care Platform (P-SHHCP) and Child Smart Holistic Health Care Platform (C-SHHCP) in people with Leukemia (Both ALL and AML) and Brain Tumors, run by National Defense Medical University, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia (Both ALL and AML), Brain Tumors
- What is being tested?
- Parent Smart Holistic Health Care Platform (P-SHHCP) and Child Smart Holistic Health Care Platform (C-SHHCP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2025to 30 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Children's Hospital
Taipei, 10041
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Leukemia (Both ALL and AML), Brain Tumors
- Being tested
- Parent Smart Holistic Health Care Platform (P-SHHCP), Child Smart Holistic Health Care Platform (C-SHHCP)
- Keywords
- Pediatric Cancer, Holistic Care, Quality of Life, Smart Holistic Health Care, Family-Centered Care, Psychosocial Support, Spiritual Well-Being
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Smart Holistic Health Care Platform (P-SHHCP)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in Cancer-Related Parenting Self-Efficacy
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in Parent Caregiver Posttraumatic Growth as Measured by the Posttraumatic Growth Inventory (PTGI)
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in Pediatric Physical and Psychosocial Health as Measured by the PROMIS Pediatric-25
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).
Measured: 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
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.
Measured: Baseline, 2 months, 5 months, and 8 months
Change in Parent Caregiver Resilience as Measured by the Connor-Davidson Resilience Scale (CD-RISC-25)
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.
Measured: 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 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.
Measured: Baseline, 2 months, 5 months, and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start30 Dec 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia (Both ALL and AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Jiuan Liaw, National Defense Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805096
- Sponsor's protocol ID
- B202505032
- Status last verified
- Jan 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No