Development of Strategies to Increase E… | Clinical Trial

Key information

Conditions

Brain and Central Nervous System Tumors Adnexal Diseases Astrocytoma Brain Diseases Brain Neoplasms Burkitt Lymphoma Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Childhood Germ Cell Tumor Choroid Plexus Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Extragonadal Germ Cell Tumor Eye Diseases Familial ependymoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioma Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hepatoblastoma Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Liver Cancer Liver Diseases Liver Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Medulloblastoma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Osteosarcoma Ovarian Cancer Ovarian Diseases Ovarian Germ Cell Cancer Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Psychosocial Effects of Cancer and Its Treatment Recurrence Rhabdoid Tumor Sarcoma Teratoma Testicular Diseases Testicular Neoplasms Tumor Virus Infections Unspecified Childhood Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Virus Diseases

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Barriers to Patient Enrollment Onto Frontline Therapeutic Clinical Trials and Development of Intervention Strategies to Increase the Proportion of Enrollment

Important dates

Study start: 1992
Primary completion: 2003
Study completion: 2005
First posted: Apr 26, 2004
Registry last updated: Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed