A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
Trial status: Open for Enrollment
Why is this study being done?
- Determine the impact of the intervention program (IP) on adherence to mercaptopurine (6MP) using the following adherence assessments: Frequency of 6MP dosing using MEMS (primary measure of adherence); 6MP dosage- and thiopurine methyltransferase (TPMT)-normalized serial red blood cell (RBC) thioguanine nucleotide (6TGN) levels; and self-report of adherence.
- Examine the modifying effect of socio-demographic and clinical characteristics as well as health beliefs/knowledge on changes in adherence with the IP.
OUTLINE: This is a multicenter study. Patients are stratified according to ethnic background (Hispanic vs non-Hispanic white vs African-American). Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a Medication Event Monitoring Systems (MEMS®) medication bottle with TrackCap™ with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap™ . Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular phone or web-based interface. Patients and caregivers are instructed to return the MEMS® medication bottle with TrackCap™ to the clinic by day 141.
- Arm II: Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I.
Patients and parents and/or caregivers in both arms complete the Demographic and the Acculturation Questionnaires on day 1. Patients and/or caregivers in arm I also complete the Adherence Questionnaires on days 29, 57, and 141 and the Intervention Rating Questionnaire on day 141.
Blood samples are collected on days 1, 29, 57, and 141 for thiopurine methyltransferase phenotyping and thioguanine nucleotide levels by high-performance chromatography.
Who is eligible to participate?
- Diagnosis of acute lymphoblastic leukemia (ALL) at < 21 years of age, in first remission (enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required)
- No patients with Down syndrome
- Belong to one of the following self-reported racial/ethnic categories: non-Hispanic white/Caucasian, Hispanic, or African-American
- Has a parent or designated caregiver (i.e., adult physically present in the household) who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine; for patients who travel between more than one household, a parent or designated caregiver will be required at each household
- Able and willing to use the Medication Event Monitoring Systems (MEMS®) TrackCap™ (e.g., not using a pillbox or prescribed liquid mercaptopurine [6MP])
- Patient and parent/caregiver must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
- Patient and parent/caregiver must speak English or Spanish
PRIOR CONCURRENT THERAPY:
- Has completed at least 24 weeks (6 months) of maintenance chemotherapy, and is scheduled to receive at least 6 more months of maintenance chemotherapy
- Receiving oral mercaptopurine (6MP) during the maintenance phase of therapy for acute lymphoblastic leukemia (ALL)