A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
6 Months
25 Years
Both
Leukemia
Trial Information
A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Adherence rate to 6MP defined as the ratio of MEMS pill container openings to the number of days that 6MP doses were prescribed during each study month
Outcome Description:
Adherence to mercaptopurine (6-MP) is an encompasses a wide spectrum of patterns from the small number of patients who take no pills at all, to the many that miss an occasional dose. Techniques of detecting non-adherence have been classified as subjective (self-report by patient/parent or healthcare provider) and objective (pill counts; electronic devices; and intracellular, plasma or urinary drug assays).
Outcome Time Frame:
Length of study
Safety Issue:
No
Principal Investigator
Smita Bhatia, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Federal Government
Study ID:
ACCL1033
NCT ID:
NCT01503632
Start Date:
February 2012
Completion Date:
Related Keywords:
- Leukemia
- childhood acute lymphoblastic leukemia in remission
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
| Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
| St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
| Blank Children's Hospital | Des Moines, Iowa 50309 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
| Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta, Georgia 30322 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Akron Children's Hospital | Akron, Ohio 44308-1062 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
| Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
| Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
| Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
| Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan 49503 |
| Legacy Emanuel Children's Hospital | Portland, Oregon 97227 |
| Children's Hospital of Alabama at University of Alabama at Birmingham | Birmingham, Alabama 35233 |
