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Effects of an electronic tool for symptom assessment and management on children aged 3-7 years with acute lymphoblastic leukemia and their family caregivers: A randomized controlled trial

Clinical application of symptom assessment and management tools for children with acute lymphoblastic leukemia aged 3-7 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105127
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukemia

Interventions

Intervention group:Symptom assessment and management intervention protocol for pediatric ALL patients

Sponsors

Fujian medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Pediatric Patients: 1.Diagnosed with Acute Lymphoblastic Leukemia (ALL), medically stable with no other serious or chronic diseases; 2.Aged 3-7 years; 3.In the initial phase of diagnosis (from diagnosis to initiation of first chemotherapy); 4.Both the child and caregiver commit to completing the full treatment course without interrupting chemotherapy; 5.Conscious and cognitively competent with ability to understand, express, and describe physical/psychological status; 6.Provide informed consent signed by the child's legal guardians. Inclusion Criteria for Caregivers: 1.Must be the caregiver of a pediatric patient meeting the aforementioned inclusion/exclusion criteria; 2.Caregivers who have received at least primary school education and possess a smartphone compatible with WeChat; 3.Serve as the primary companion throughout the child's treatment course.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Pediatric Patients: 1.Having received or currently receiving similar digital health interventions within the past 3 months; 2.Karnofsky Performance Status (KPS) score <50%, or presence of cognitive impairments that would preclude the operation of smart applications. Exclusion Criteria for Caregivers: 1.History of psychiatric disorders or cognitive impairment; 2.Presence of speech disorders causing communication difficulties.

Design outcomes

Primary

MeasureTime frame
Symptom burden;Care burden;

Secondary

MeasureTime frame
Quality of life for children;Quality of life for caregivers;Uncertainty about the disease;Anxiety;Depression;Satisfaction;

Countries

China

Contacts

Public ContactRong Hu

School of Nursing, Fujian Medical University

ronghu1246@fjmu.edu.cn+86 138 6062 3495

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026