Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia

Not Applicable

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Other: High Intensity; Other: No Text Messagings; Other: Low Intensity Text Messaging

• Registration Number: NCT06446661
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Young Adults (AYA) with Acute Lymphoblastic leukemia (ALL).

Detailed Description

This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult patients with Acute Lymphoblastic Leukemia on pediatric-based regimens 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 Timeline

• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Study Start: 2025-12-15
• Primary Completion: 2027-06-15
• Study Completion: 2028-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Age of 15-39 years-old at the time of initial ALL diagnosis
• Diagnosed with ALL
• 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity	High Intensity	Receives high-intensity text messaging for 2 cycles of treatment
Low Intensity	Low Intensity Text Messaging	Receives no texts for 1st cycle and low-intensity texts for 2nd cycle
Low Intensity	No Text Messagings	Receives no texts for 1st cycle and low-intensity texts for 2nd cycle

Primary Outcome Measures

Name	Time	Method
To compare adherence to oral chemotherapy with mercaptopurine and methotrexate	84 days	To compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for AYA patients with ALL on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard of care.

Secondary Outcome Measures

Name	Time	Method
To describe the relationship between oral chemotherapy adherence and AYA patient factors	1 year	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.

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States