About this trial
The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Adults with Acute Lymphoblastic leukemia (ALL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
High Intensity
Other interventionDaily texts
No Text Messagings
Other interventionStandard Care
Low Intensity Text Messaging
Other interventionWeekly Texts
Treatment groups
Trial outcomes
Primary outcomes
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 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 outcomes
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.
Other outcomes
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
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.
Sponsors and contacts
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