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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Lymphoblastic Leukemia; T-cell Lymphoblastic Lymphoma
• Intervention / Treatment: Other: High Intensity; Other: No Text Messagings; Other: Low Intensity Text Messaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Intake; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University Of Chicago Medicine Comprehensive Cancer Center
      • Contact: Clinical Trials Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu
      • Principal Investigator: Austin Wesevich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Efficacy Phase: High Intensity Messaging; Receives high-intensity text messaging for 2 cycles of treatment	Other: High Intensity; Daily texts
Active Comparator: Efficacy Phase: Low Intensity Messaging; Receives no texts for 1st cycle and low-intensity texts for 2nd cycle	Other: No Text Messagings; Standard Care; Other: Low Intensity Text Messaging; Weekly Texts
Experimental: Pilot Phase Arm; Participants receive high-intensity text messaging for 28 days	Other: High Intensity; Daily texts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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) .	168 days after completion of enrollment to efficacy phase of study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare clinical outcomes during and after maintenance therapy for AYA patients	Any changes in chemotherapy regimen or evidence of relapsed disease including new minimal residual disease (MRD) positivity within the first year of maintenance will be recorded.	1 year
To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for patients	ANC and platelet measurements are collected throughout maintenance to monitor for therapeutic goals and the potential need for dose changes as part of AYA Oncology pharmacist-led management program	1 year

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Austin Wesevich, University Of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Oral Chemotherapy
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: IRB23-1519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No