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Sponsors and Collaborators: |
Pediatric Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002485 |
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.
Condition | Intervention |
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Brain and Central Nervous System Tumors Cancer-Related Problem/Condition Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Leukemia Liver Cancer Lymphoma Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Official Title: | BARRIERS TO PATIENT ENROLLMENT ONTO FRONTLINE THERAPEUTIC CLINICAL TRIALS AND DEVELOPMENT OF INTERVENTION STRATEGIES TO INCREASE THE PROPORTION OF ENROLLMENT |
Study Start Date: | February 1992 |
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | Brad H. Pollock, PhD | Pediatric Oncology Group Statistical Office |
Study ID Numbers: | CDR0000077305, POG-9284/9285, NCI-P92-0003 |
Study First Received: | November 1, 1999 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00002485 |
Health Authority: | United States: Federal Government |
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 |
Liver Diseases Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Urogenital Neoplasms Central Nervous System Neoplasms Small non-cleaved cell lymphoma Osteogenic sarcoma Neoplasms, Connective and Soft Tissue Neuroepithelioma Glioma Hepatoblastoma Hodgkin Disease Nervous System Neoplasms Endocrine Gland Neoplasms Lymphoma, Large B-Cell, Diffuse |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Digestive System Neoplasms Immunoproliferative Disorders Astrocytoma Acute myelogenous leukemia Myeloproliferative Disorders Genital Neoplasms, Female Endocrine System Diseases Testicular Neoplasms Leukemia, Myeloid Rhabdoid tumor Neuroectodermal Tumors Hodgkin lymphoma, childhood Sarcoma Gastrointestinal Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial Adnexal Diseases |