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BARRIERS TO PATIENT ENROLLMENT ONTO FRONTLINE THERAPEUTIC CLINICAL TRIALS AND DEVELOPMENT OF INTERVENTION STRATEGIES TO INCREASE THE PROPORTION OF ENROLLMENT


N/A
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Leukemia, Liver Cancer, Lymphoma, Neuroblastoma, Ovarian Cancer, Psychosocial Effects of Cancer and Its Treatment, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Case or control patient clinically eligible for a Pediatric
Oncology Group (POG) frontline therapeutic protocol, whether or not the protocol was
submitted to or approved by the physician's Institutional Review Board Case patients must
not have enrolled on the POG frontline protocol due to decision by the physician or
patient/parent Control patients must have been enrolled on the POG frontline protocol
Ineligible if offered treatment on an in-house therapeutic protocol (institutional review
board-approved) rather than the POG protocol

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

Brad H. Pollock, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Pediatric Oncology Group Statistical Office

Authority:

United States: Federal Government

Study ID:

CDR0000077305

NCT ID:

NCT00002485

Start Date:

February 1992

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Leukemia
  • Liver Cancer
  • Lymphoma
  • Neuroblastoma
  • Ovarian Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • localized osteosarcoma
  • metastatic osteosarcoma
  • recurrent childhood acute lymphoblastic leukemia
  • childhood infratentorial ependymoma
  • childhood low-grade cerebral astrocytoma
  • childhood supratentorial ependymoma
  • childhood craniopharyngioma
  • localized resectable neuroblastoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • stage 4S neuroblastoma
  • recurrent neuroblastoma
  • stage I childhood liver cancer
  • stage II childhood liver cancer
  • stage III childhood liver cancer
  • stage IV childhood liver cancer
  • recurrent childhood liver cancer
  • childhood hepatoblastoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • childhood central nervous system germ cell tumor
  • recurrent childhood acute myeloid leukemia
  • recurrent osteosarcoma
  • unspecified childhood solid tumor, protocol specific
  • childhood germ cell tumor
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • stage II childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • extragonadal germ cell tumor
  • childhood high-grade cerebral astrocytoma
  • childhood oligodendroglioma
  • childhood choroid plexus tumor
  • childhood meningioma
  • localized unresectable neuroblastoma
  • psychosocial effects of cancer and its treatment
  • stage I childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • untreated childhood brain stem glioma
  • recurrent childhood brain stem glioma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood cerebellar astrocytoma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • untreated childhood medulloblastoma
  • recurrent childhood medulloblastoma
  • untreated childhood visual pathway and hypothalamic glioma
  • recurrent childhood visual pathway and hypothalamic glioma
  • newly diagnosed childhood ependymoma
  • recurrent childhood ependymoma
  • childhood teratoma
  • childhood malignant testicular germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood extragonadal germ cell tumor
  • recurrent childhood malignant germ cell tumor
  • childhood atypical teratoid/rhabdoid tumor
  • Leukemia
  • Liver Neoplasms
  • Lymphoma
  • Nervous System Neoplasms
  • Neuroblastoma
  • Ovarian Neoplasms
  • Lymphoma, Non-Hodgkin
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Sarcoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Tomorrows Children's InstituteHackensack, New Jersey  07601
Mount Sinai School of MedicineNew York, New York  10029
Memorial Mission HospitalAsheville, North Carolina  28801
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Rhode Island HospitalProvidence, Rhode Island  02903
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
West Virginia University - Charleston DivisionCharleston, West Virginia  25302
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226