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A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL


Phase 3
6 Months
25 Years
Open (Enrolling)
Both
Leukemia

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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 PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Driscoll Children's HospitalCorpus Christi, Texas  78466
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Southern California Permanente Medical GroupDowney, California  90242
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Childrens Hospital Los AngelesLos Angeles, California  90027
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Akron Children's HospitalAkron, Ohio  44308-1062
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Riley's Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503
Legacy Emanuel Children's HospitalPortland, Oregon  97227
Children's Hospital of Alabama at University of Alabama at BirminghamBirmingham, Alabama  35233