Acute Lymphoblastic Leukemia
Conditions
Keywords
Oral Chemotherapy
Brief summary
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).
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.
Interventions
OTHERHigh Intensity
Daily texts
OTHERNo Text Messagings
Standard Care
OTHERLow Intensity Text Messaging
Weekly Texts
Sponsors
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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 * Text messages will be crafted in the patient's preferred language for medical communication, so English fluency is not an enrollment requirement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| To describe the relationship between oral chemotherapy adherence and 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. |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORWendy Stock
University of Chicago
Outcome results
None listed