Spots Global Cancer Trial Database for Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
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Trial Identification
Brief Title: Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission
Official Title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
Study ID: NCT01503632
Conditions
Study Description
Brief Summary: This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the impact of interventions proposed in intervention program (IP) versus (vs.) education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure). SECONDARY OBJECTIVES: I. Examine the modifying effect of sociodemographic and psychosocial variables, and the mediating effect of health beliefs/ knowledge on change in adherence with intervention. II. Determine impact of IP vs. EDU on risk of relapse of ALL. OUTLINE: Patients are randomized to 1 of 2 intervention arms. ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a MEMSĀ® medication bottle with TrackCapā¢ 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 MEMSĀ® medication bottle with TrackCapā¢. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCapā¢ 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 MEMSĀ® medication bottle with TrackCapā¢ to the clinic by day 141. ARM II: Patients receive the usual standard of care and the mercaptopurine from the MEMSĀ® medication bottle with TrackCapā¢ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29. After completion of study treatment, patients are followed up every 6 months for 5 years and then annually until 10 years from diagnosis.
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Mattel Children's Hospital UCLA, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lee Memorial Health System, Fort Myers, Florida, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Children's Hospital New Orleans, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States
Summerlin Hospital Medical Center, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albany Medical Center, Albany, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
New York Medical College, Valhalla, New York, United States
Mission Hospital, Asheville, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
Mercy Children's Hospital, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital, Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Vannie Cook Children's Clinic, McAllen, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Carilion Children's, Roanoke, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
San Jorge Children's Hospital, San Juan, , Puerto Rico
University Pediatric Hospital, San Juan, , Puerto Rico
Contact Details
Name: Smita Bhatia
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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