NCT03932903 · Northwestern University
Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia
What this study is about
This is a small-scale micro-randomly assigned clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote taken by mouth chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.
View original scientific description
This is a small-scale micro-randomized clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote oral chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.
Interventions
BEHAVIORAL
ADAPTS (ADherence Assessments and Personalized Timely Support).
ADAPTS is a mobile app intervention that integrates contextually-tailored mobile messages and decision rules about when to deliver the messages, with the ultimate goal of improving oral chemotherapy adherence in AYAs with acute lymphoblastic leukemia and lymphoma. AYA participants will be micro-randomized to receive messages on some days that are adapted to their current characteristics (e.g., mood, pain, location) and designed to promote adherence, and no messages (no intervention) on other days. Other features in the app include a medication calendar that syncs with the electronic medication monitor (eCAP) to track daily adherence. A caregiver version of ADAPTS is also available, providing daily surveys (but no randomized mobile messages) and the medication calendar so that dyads can mutually track adherence.
Primary outcome measures
Technical Difficulties
Time frame: 28-day intervention period
Number of technical glitches and errors experienced in implementing the intervention
Retention Rate
Time frame: Up to 12 months
Number of AYA (and caregiver) subjects who complete the intervention, out of the total number of subjects enrolled in the study (target of 75% or more)
Screening Rate
Time frame: Up to 12 months
Number of AYA patients (and matched caregivers) referred and screened for the study
Intervention Engagement
Time frame: 28-day intervention period
Number of 1) viewed and 2) acknowledged micro-randomized text messages
Recruitment Rate
Time frame: Up to 12 months
Number of AYA patients (and matched caregivers) enrolled in the study out of those who were eligible and invited to participate (target of 75% or more)
Intervention Acceptability
Time frame: At completion of 28-day intervention period
5-point numerical Likert scale; ranging from 0 (not at all) to 4 (completely) to rate intervention acceptability (including satisfaction, appropriateness, perceived positive effects, potential for future use).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations