NCT06446661 · University of Chicago
Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
What this study is about
This is a single center 2-phase study to assess effects of using text messages on adherence to taken by mouth chemotherapy for patients with acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma.
View original scientific description
This is a single center 2-phase study to assess effects of using text messages on adherence to oral chemotherapy for patients with acute lymphoblastic leukemia (ALL) or T-cell lymphoblastic lymphoma.
Interventions
OTHER
High Intensity
Daily texts
OTHER
No Text Messagings
Standard Care
OTHER
Low Intensity Text Messaging
Weekly Texts
Primary outcome measures
To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase)
Time frame: 84 days after completion of enrollment to efficacy phase of study
Adherence to chemotherapy regimen will be measured based on combined data from 8.1 Medication Event Monitoring System (MEMS) TrackCap devices which measure the number of times pill bottles are opened, responses to Medication Adherence Report Scale (MARS-5) questionnaire, number of pharmacy fills, and mean corpuscular volume (MCV) .
Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase)
Time frame: 28 days after completion of enrollment to pilot phase of study
Feasibility will be measured based on participant responses to validated questionnaires - Feasibility of intervention measure (FIM) and Acceptability of intervention measure (AIM). Both forms are 4 items scored on a 5 point Likert scale. Scores greater than or equal to 16 will determine whether the intervention is feasible.
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
- Age of 15 years or older at time of enrollment
- Diagnosed with ALL or T-cell lymphoblastic lymphoma
- Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance. Patients in the pilot phase may have already started maintenance as long as the end of their maintenance therapy is scheduled to occur after the end of the 28-day pilot intervention.
Exclusion criteria
- Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
- Patient does not wish to participate
- Text messages will be crafted in the patient's preferred language for medical communication, so English fluency is not an enrollment requirement.
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 Jul 10, 2026 · Source of record for eligibility and locations