An interventional study of High Intensity and No Text Messagings in Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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.
The study will begin with a 28-day pilot phase where participants will be asked to complete questionnaires to determine if the text message intervention is acceptable to participants.
In the efficacy phase, the study will compare adherence to oral mercaptopurine and methotrexate between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 48 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receives high-intensity text messaging for 2 cycles of treatment
Other: High Intensity
Receives no texts for 1st cycle and low-intensity texts for 2nd cycle
Other: No Text Messagings · Other: Low Intensity Text Messaging
Participants receive high-intensity text messaging for 28 days
Other: High Intensity
Daily texts
Standard Care
Weekly Texts
To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase)
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) .
Time frame: 84 days after completion of enrollment to efficacy phase of study
Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase)
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.
Time frame: 28 days after completion of enrollment to pilot phase of study
To describe the relationship between oral chemotherapy adherence and patient factors
At the start of cycle 1, Health Competence Beliefs Inventory (HCBI) scores will be collected as a baseline measurement of self-efficacy as measured in a prior AYA adherence study. Higher HCBI scores and lower ADI and SVM scores will be associated with higher adherence given prior associations with self-efficacy and family finances.
Time frame: 1 year
To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase)
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) .
Time frame: 168 days after completion of enrollment to efficacy phase of study
Plan to share: No — Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally. Data will only be shared for analysis purposes.
No publications or documents are linked to this record.
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