Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Intensity, No Text Messagings, Low Intensity Text Messaging.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
Overview
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
- Other High Intensity
Daily texts - Other No Text Messagings
Standard Care - Other Low Intensity Text Messaging
Weekly Texts
Primary outcome measures
- To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase) [Time frame: 84 days after completion of enrollment to efficacy phase of study]
- Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase) [Time frame: 28 days after completion of enrollment to pilot phase of study]
Secondary outcome measures (2)
- To describe the relationship between oral chemotherapy adherence and patient factors [Time frame: 1 year]
- To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase) [Time frame: 168 days after completion of enrollment to efficacy phase of study]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Chicago Medicine Comprehensive Cancer Center — Chicago
Identifiers
NCT: NCT06446661 · IRB23-1519