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NCT Number: NCT06446661

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

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.

Recruiting

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Austin Wesevich

PRINCIPAL_INVESTIGATOR

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity

Other

Daily texts

No Text Messagings

Other

Standard Care

Low Intensity Text Messaging

Other

Weekly Texts

Primary outcomes

  1. 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

    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) .

  2. 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

    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 outcomes

  1. To describe the relationship between oral chemotherapy adherence and patient factors

    Time frame: 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.

  2. 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

    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) .

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 6, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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