Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedStudy Start
First participant enrolled
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2028
July 10, 2026
July 1, 2026
1.1 years
May 31, 2024
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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) .
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.
28 days after completion of enrollment to pilot phase of study
Secondary Outcomes (2)
To describe the relationship between oral chemotherapy adherence and patient factors
1 year
To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase)
168 days after completion of enrollment to efficacy phase of study
Study Arms (3)
Efficacy Phase: High Intensity Messaging
ACTIVE COMPARATORReceives high-intensity text messaging for 2 cycles of treatment
Efficacy Phase: Low Intensity Messaging
ACTIVE COMPARATORReceives no texts for 1st cycle and low-intensity texts for 2nd cycle
Pilot Phase Arm
EXPERIMENTALParticipants receive high-intensity text messaging for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin Wesevich
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 6, 2024
Study Start
May 19, 2026
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
June 15, 2028
Last Updated
July 10, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.