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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorUniversity of Chicago

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • High Intensity

    Other intervention

    Daily texts

  • No Text Messagings

    Other intervention

    Standard Care

  • Low Intensity Text Messaging

    Other intervention

    Weekly Texts

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: High IntensityActive comparator 1 intervention
Group B: Low IntensityActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
84 days

Secondary outcomes

1

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.

Time frame
1 year

Other outcomes

1

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

Time frame
1 year
2

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.

Time frame
1 year

Sponsors and contacts

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