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NCT06446661 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Young Adults With Acute Lymphoblastic Leukemia Using Text Messages

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06446661
Other study ID # IRB23-1519
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date June 15, 2028

Study information
Verified date May 2024
Source University of Chicago
Contact Clinical Trials Intake
Phone 1-855-702-8222
Email cancerclinicaltrials@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 38
Est. completion date June 15, 2028
Est. primary completion date June 15, 2027
Accepts healthy volunteers No
Gender All
Age group 15 Years to 39 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• High Intensity
Daily texts
• No Text Messagings
Standard Care
• Low Intensity Text Messaging
Weekly Texts

Locations
Country Name City State
United States University of Chicago Medicine Comprehensive Cancer Center Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for AYA 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
Other 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
Primary To compare adherence to oral chemotherapy with mercaptopurine and methotrexate 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. 84 days
Secondary To describe the relationship between oral chemotherapy adherence and AYA 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
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