Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
- Conditions
- Childhood Germ Cell TumorExtragonadal Germ Cell TumorLeukemiaLymphomaNeuroblastomaOvarian CancerLiver CancerPsychosocial Effects of Cancer and Its TreatmentSarcomaUnspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Procedure: psychosocial assessment and care
- Registration Number
- NCT00002485
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Taking part in a clinical trial may help children with cancer receive more effective treatment.
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 359
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stratum 1 psychosocial assessment and care Not Enrolled / No IRB Applied Stratum 2 psychosocial assessment and care Not Enrolled / IRB Approved
- Primary Outcome Measures
Name Time Method Determine why eligible patients are not enrolled on available Pediatric Oncology Group therapeutic clinical trials. The variables of interest are those factors that affect the decision by the treating physician or patient/parent to refuse enrollment onto study.
Physician responses and patient/parent responses as to reasons for non-enrollment will be compared. Analyses will assess patient demographic factors and institutional characteristics (including the size of the treating institution in terms of the number of patients enrolled on protocols annually). Additionally, reasons for non-enrollment will be assessed with regard to the size of the institution's cancer care program.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Tomorrows Children's Institute
🇺🇸Hackensack, New Jersey, United States
Memorial Mission Hospital
🇺🇸Asheville, North Carolina, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
West Virginia University - Charleston Division
🇺🇸Charleston, West Virginia, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
🇺🇸Lackland Air Force Base, Texas, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Clinique de Pediatrie
🇨ðŸ‡Geneva, Switzerland
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, 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
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States