Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer

Lymphoma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lymphoma
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Neuroblastoma
• Ovarian Cancer
• Psychosocial Effects of Cancer and Its Treatment
• Sarcoma
• Unspecified Childhood Solid Tumor, Protocol Specific

• NCT number: NCT00002485
• Study type: Observational
• Source: Children's Oncology Group
• Status: Completed
• Phase: N/A
• Start date: February 1992
• Completion date: September 2005