Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
Conditions
Keywords
Oral Chemotherapy
Brief summary
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.
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.
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 No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase) | 84 days after completion of enrollment to efficacy phase of study | 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) . |
| Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase) | 28 days after completion of enrollment to pilot phase of study | 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. |
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. |
| To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase) | 168 days after completion of enrollment to efficacy phase of study | 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) . |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORAustin Wesevich
University of Chicago
Outcome results
None listed