BARRIERS TO PATIENT ENROLLMENT ONTO FRONTLINE THERAPEUTIC CLINICAL TRIALS AND DEVELOPMENT OF INTERVENTION STRATEGIES TO INCREASE THE PROPORTION OF ENROLLMENT
OBJECTIVES: I. Identify prospectively physician and patient factors associated with reasons
why patients who are eligible for Pediatric Oncology Group therapeutic protocols are not
enrolled onto such studies. II. Provide information that may be used to develop intervention
strategies to decrease barriers to patient enrollment, thus increasing enrollment in
therapeutic protocols.
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.
Interventional
N/A
Brad H. Pollock, PhD
Study Chair
Pediatric Oncology Group Statistical Office
United States: Federal Government
CDR0000077305
NCT00002485
February 1992
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of California Davis Medical Center | Sacramento, California 95817 |
Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
CCOP - Florida Pediatric | Tampa, Florida 33682-7757 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
Tomorrows Children's Institute | Hackensack, New Jersey 07601 |
Mount Sinai School of Medicine | New York, New York 10029 |
Memorial Mission Hospital | Asheville, North Carolina 28801 |
Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
Oklahoma Memorial Hospital | Oklahoma City, Oklahoma 73126-0307 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
West Virginia University - Charleston Division | Charleston, West Virginia 25302 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |