ACCL1033, A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

Study ID
STU 102012-057

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
McGinn Stephanie
214 456-8588
stephanie.mcginn@childrens.com

Principal Investigator
Naomi Winick

Summary

all eligible, consenting participants will be given a Patient Supply Kit which contains a special medication bottle (MeMS). each participant will be asked to have all 6MP prescriptions filled into the MeMS medication bottle throughout the study. The MeMS medication bottle will be fitted with a special cap (TrackCapTM CR) that electronically records when the medication bottle is opened throughout the study.

each participant will be randomly assigned to one of two intervention plans:

-- arm iP: Children/teens will receive multimedia interactive patient education
(parents and patients [Greater Than]age 12 years), a customized medication schedule, medication reminders (cell phone text messages x parents and patients [Greater Than] age 12 years) and parent/caregiver training to supervise the child or teen's taking of medication
-- arm eDu: Children/teens will receive multimedia interactive patient education (parents and patients [Greater Than] age 12 years) in addition to usual care (whatever is normally done at their clinic to help people with taking their medications as directed)
Taking part in this study will not change the maintenance treatment a participant will receive for aLL.

Participant Eligibility

(1) Diagnosis of ALL at >= 1 year and <= 21 years of age, in first remission. Enrollment on a COG therapeutic study for ALL is not required.
(2) Age <= 25 years at the time of study enrollment
(3) Has completed at least 24 weeks (6 months) of maintenance chemotherapy, and is scheduled to
receive at least 6 more months of maintenance chemotherapy
(4) Receiving oral 6MP during the maintenance phase of therapy for ALL
(5) Had a designated parent or cargiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine.
(6) Able and willing to use the MEMS(RegisteredTM) TrackCap(TM) (e.g., not using a pillbox or prescribed liquid
6MP)
(7) Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
(8) Patient and parent/caregiver must speak English or Spanish