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+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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 interventionDaily texts
No Text Messagings
Other interventionStandard Care
Low Intensity Text Messaging
Other interventionWeekly Texts
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Efficacy Phase: High Intensity MessagingActive comparator 1 intervention
Group B: Efficacy Phase: Low Intensity MessagingActive comparator 2 interventions
Group C: Pilot Phase ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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) .
Time frame
84 days after completion of enrollment to efficacy phase of study2
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.
Time frame
28 days after completion of enrollment to pilot phase of studySecondary 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 year2
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) .
Time frame
168 days after completion of enrollment to efficacy phase of studySponsors and contacts
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Source ClinicalTrials.gov