Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
NCT ID: NCT00002485
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
359 participants
OBSERVATIONAL
1992-02-29
2005-09-30
Brief Summary
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PURPOSE: Determine why patients who are eligible for protocols made available through the Pediatric Oncology Group do not enroll in them, and develop strategies to increase enrollment on these clinical trials.
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Detailed Description
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OUTLINE: This is a case-control, multicenter study. Case patients are stratified. Stratum 1 comprises patients for whom there is an appropriate Pediatric Oncology Group (POG) frontline therapeutic protocol that has not yet been submitted to, disapproved by, or approved by the Institutional Review Board (IRB). Stratum 2 comprises patients for whom there is an appropriate POG frontline therapeutic protocol that has been approved by the IRB. Physicians complete an IRB submission form for their patients on stratum 1. Patients/parents on stratum 2 who refused enrollment and their primary physicians complete questionnaires that address reasons for nonenrollment. Control patients/parents who consented to enrollment complete questionnaires that address reasons for enrollment. Demographic information, including the size of the treating institution and the annual number of patients enrolled onto its protocols, is collected. Additional demographic information regarding the patient and his or her family is collected.
PROJECTED ACCRUAL: A total of 595 case patients (12 with soft tissue sarcoma, 34 with osteosarcoma, 19 with brain tumors, 32 with Hodgkin's disease, 60 with non-Hodgkin's lymphoma, 278 with acute lymphoblastic leukemia, 65 with acute non-lymphoblastic leukemia, 56 with neuroblastoma, 14 with hepatoblastoma, and 25 with germ cell tumors) will be accrued for this study within 7 years. Corresponding control patients will be accrued for this study.
Conditions
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Study Groups
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Stratum 1
Not Enrolled / No IRB Applied
psychosocial assessment and care
Stratum 2
Not Enrolled / IRB Approved
psychosocial assessment and care
Interventions
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psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Brad H. Pollock, PhD
Role: STUDY_CHAIR
Pediatric Oncology Group Statistical Office
Locations
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University of California Davis Medical Center
Sacramento, California, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
CCOP - Florida Pediatric
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
CCOP - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Tomorrows Children's Institute
Hackensack, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Memorial Mission Hospital
Asheville, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Vermont Cancer Center
Burlington, Vermont, United States
West Virginia University - Charleston Division
Charleston, West Virginia, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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Other Identifiers
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POG-9284/9285
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P92-0003
Identifier Type: -
Identifier Source: secondary_id
CDR0000077305
Identifier Type: OTHER
Identifier Source: secondary_id
9284
Identifier Type: -
Identifier Source: org_study_id
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