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Recruiting NCT07278882

Using Mobile Technology-assisted Outpatient Maintenance Therapy Pediatric ALL

No phase Interventional Pediatric Acute Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health monitoring & reminders for a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment..
Who it may be relevant to
Registry conditions: Pediatric Acute Leukemia. Basic parameters: up to 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Controlled Trial of Mobile Technology-assisted Outpatient Maintenance Therapy in Children With Acute Lymphoblastic Leukaemia (ALL)

Overview

To assess the efficacy of using mobile technology to improve the percentage of time wherein drug dosing is within the target range

Interventions

  • Behavioral Health monitoring & reminders for a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.
    Subjects classified as 'Orange Alert' receive mobile-phone alert messages that instruct them to self-adjust dose of oral medication. Subjects classified as 'Red Alert' are directed to a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.

Primary outcome measures

  • Percentage of time wherein white blood cell concentration is within the target range [Time frame: After randomization]
Secondary outcome measures (1)
  • Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L [Time frame: After randomization]

Eligibility criteria

Inclusion criteria

  • < 16 years old at diagnosis;
  • having demonstrated ≥ 3 months of > 90% compliance with using a mobile app to log in records of daily medication and weekly blood test results;
  • no further in-hospital chemotherapy;
  • patient or legal guardian provides informed consent.

Exclusion criteria

None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT07278882 · IIT2024105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗