Mobile app to help teens and young adults take their daily oral leukemia medicine
Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
NA · Northwestern University · NCT03932903
This project tests a smartphone app that sends tailored reminders and messages to help adolescents and young adults with acute lymphoblastic leukemia or lymphoblastic lymphoma take their daily 6-mercaptopurine during maintenance therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT03932903 on ClinicalTrials.gov |
What this trial studies
This is a two-month pilot using electronic pill caps to monitor baseline adherence for 28 days, followed by a 28-day micro-randomized just-in-time adaptive intervention (JITAI) called ADAPTS. ADAPTS delivers daily ecological momentary assessments and contextually tailored messages to adolescents and young adults, with a parallel caregiver app option. The micro-randomized design randomizes message delivery elements over time to learn which prompts help most in real-world moments. The app is available for Android and Apple devices and collects participant feedback on each message to refine support.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescents and young adults aged 14–29 with ALL or lymphoblastic lymphoma who are in maintenance therapy, prescribed 6-mercaptopurine, and able to use an Android or Apple smartphone (with caregiver consent if under 18).
Not a fit: Patients who are not in maintenance, not prescribed 6-MP, have significant cognitive impairments that limit participation, lack a compatible smartphone, or already have perfect adherence are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the app could improve daily 6-MP adherence in AYAs and thereby reduce the risk of relapse during maintenance therapy.
How similar studies have performed: Similar mobile reminder and JITAI approaches have shown promise for improving adherence in chronic illnesses and some oncology contexts, but a micro-randomized JITAI targeting AYA 6-MP adherence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
AYA Inclusion Criteria: * Ages 14-29 * Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma * In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining. * Prescribed 6-mercaptopurine (6MP) * English language proficiency * For AYA \<18, must have informed consent from their caregiver. AYA Exclusion Criteria: * Cognitive impairments that would limit ability to complete measures, determined by the medical team * Absence of inclusion criteria above. Caregiver Inclusion Criteria: * Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend) * English language proficiency Caregiver Exclusion Criteria: \- Absence of inclusion criteria above.
Where this trial is running
Chicago, Illinois
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Alexandra M Psihogios, Ph.D. — Northwestern University
- Study coordinator: Alexandra M Psihogios, Ph.D.
- Email: alex.psihogios@northwestern.edu
- Phone: 312-503-3577
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.
Conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Adherence, Adolescent, Young Adult, Mobile Health, Oncology