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
NCT Number: NCT06446661
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.
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
Location status: Recruiting
Austin Wesevich
PRINCIPAL_INVESTIGATOR
Clinical Trials Intake
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily texts
Standard Care
Weekly Texts
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) .
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.
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.
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) .
Contact information is provided by the study sponsor or research team.
University of Chicago
Other
Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Adults With Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma Using Text Messages
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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