Mobile technology–assisted maintenance therapy for children with acute lymphoblastic leukemia
A Randomized Controlled Trial of Mobile Technology-assisted Outpatient Maintenance Therapy in Children With Acute Lymphoblastic Leukaemia (ALL)
This study will try a mobile phone app with reminders and telemedicine scheduling to help children with acute lymphoblastic leukemia keep their medication dosing in the target range.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07278882 on ClinicalTrials.gov |
What this trial studies
Children with acute lymphoblastic leukemia who are completing outpatient maintenance therapy and have already shown high compliance with a mobile app will use a mobile-phone portal that schedules telemedicine clinic visits and sends periodic messages with instructions for follow-up blood testing and dose adjustment. The intervention combines remote reminders, logging of daily medication and weekly blood test results, and telemedicine scheduling to prompt timely dose modifications. The primary outcome is the percentage of time that drug dosing remains within the prespecified therapeutic target range. The study is conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin, China.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed before age 16 who have already demonstrated at least three months of over 90% compliance using a mobile app to log daily medication and weekly blood tests, are no longer receiving in-hospital chemotherapy, and whose parent or legal guardian can provide informed consent.
Not a fit: Children who lack reliable mobile phone access or connectivity, who require ongoing in-hospital chemotherapy, or whose drug levels remain unpredictable despite adherence are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, this approach could increase the amount of time children keep their medication dosing within the therapeutic target, potentially reducing relapse risk and limiting toxicity from improper dosing.
How similar studies have performed: Previous studies using mobile reminders and telemedicine have improved medication adherence in pediatric chronic conditions, but applying these tools specifically to maintain chemotherapy drug levels in pediatric ALL is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \< 16 years old at diagnosis; 2. having demonstrated ≥ 3 months of \> 90% compliance with using a mobile app to log in records of daily medication and weekly blood test results; 3. no further in-hospital chemotherapy; 4. patient or legal guardian provides informed consent. Exclusion Criteria: None
Where this trial is running
Tianjin, Tianjin Municipality
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yahui Feng
- Email: fengyahui@ihcams.ac.cn
- Phone: 022-23909051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.