Acute Lymphoblastic LeukemiaNCT06446661
Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia
A study testing High Intensity, No Text Messagings and Low Intensity Text Messaging in people with Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
- What is being tested?
- High Intensity, No Text Messagings and Low Intensity Text Messaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2026to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Austin Wesevich
About this study
Official title: Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
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.
Read the 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.
- Being tested
- High Intensity, No Text Messagings, Low Intensity Text Messaging
- Keywords
- Oral Chemotherapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High IntensityOther
Daily texts
No Text MessagingsOther
Standard Care
Low Intensity Text MessagingOther
Weekly Texts
| Study group | Role | What they receive |
|---|---|---|
| Efficacy Phase: High Intensity Messaging | Active comparator | Receives high-intensity text messaging for 2 cycles of treatment Receives: Other: High Intensity |
| Efficacy Phase: Low Intensity Messaging | Active comparator | Receives no texts for 1st cycle and low-intensity texts for 2nd cycle Receives: Other: No Text Messagings; Other: Low Intensity Text Messaging |
| Pilot Phase Arm | Experimental | Participants receive high-intensity text messaging for 28 days Receives: Other: High Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare adherence to oral chemotherapy between study groups for first treatment cycle (Efficacy Phase)
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) .
Measured: 84 days after completion of enrollment to efficacy phase of study
Feasibility of text message interventions to improve adherence to oral chemotherapy (Pilot Phase)
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.
Measured: 28 days after completion of enrollment to pilot phase of study
Secondary outcomes (2)
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.
Measured: 1 year
To compare adherence to oral chemotherapy between study groups for second treatment cycle (Efficacy Phase)
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) .
Measured: 168 days after completion of enrollment to efficacy phase of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start19 May 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Wesevich, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446661
- Sponsor's protocol ID
- IRB23-1519
- Status last verified
- Jul 2026
- First submitted
- 31 May 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally. Data will only be shared for analysis purposes.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
- ClinicalTrials.gov ID
- NCT06446661
- Acronym / sponsor ID
- IRB23-1519
- Keywords
- Oral Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efficacy Phase: High Intensity Messaging | Active comparator | Other: High IntensityReceives high-intensity text messaging for 2 cycles of treatment |
| Efficacy Phase: Low Intensity Messaging | Active comparator | Other: No Text Messagings, Other: Low Intensity Text MessagingReceives no texts for 1st cycle and low-intensity texts for 2nd cycle |
| Pilot Phase Arm | Experimental | Other: High IntensityParticipants receive high-intensity text messaging for 28 days |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High IntensityDaily texts | Other | Efficacy Phase: High Intensity Messaging, Pilot Phase Arm |
| No Text MessagingsStandard Care | Other | Efficacy Phase: Low Intensity Messaging |
| Low Intensity Text MessagingWeekly Texts | Other | Efficacy Phase: Low Intensity Messaging |
Primary outcome
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) .
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally. Data will only be shared for analysis purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Austin Wesevich principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity, No Text Messagings and Low Intensity Text Messaging in people with Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.