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

Completed

• Conditions: Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Leukemia; Lymphoma; Neuroblastoma; Ovarian Cancer; Liver Cancer; Psychosocial Effects of Cancer and Its Treatment; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific

• 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.

Study Timeline

• Study Start: 1992-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-07
• Study First Submitted QC: 2004-04-23
• Study First Posted: 2004-04-26
• Study Completion: 2005-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (31)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Shands Hospital and Clinics, University of Florida; 🇺🇸 Gainesville, Florida, United States

Sylvester Cancer Center, University of Miami; 🇺🇸 Miami, Florida, United States

CCOP - Florida Pediatric; 🇺🇸 Tampa, Florida, United States

Emory University Hospital - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Tripler Army Medical Center; 🇺🇸 Honolulu, Hawaii, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

MBCCOP - LSU Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

Hurley Medical Center; 🇺🇸 Flint, Michigan, United States

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