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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002485
• Other study ID #: 9284
• Secondary ID: POG-9284/9285NCI
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: February 12, 2014
• Start date: February 1992
• Est. completion date: September 2005

Study information

• Verified date: February 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: September 2005
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 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

Intervention

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
Switzerland	Clinique de Pediatrie	Geneva
United States	Memorial Mission Hospital	Asheville	North Carolina
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Vermont Cancer Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	West Virginia University - Charleston Division	Charleston	West Virginia
United States	Presbyterian Healthcare	Charlotte	North Carolina
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Shands Hospital and Clinics, University of Florida	Gainesville	Florida
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	Tomorrows Children's Institute	Hackensack	New Jersey
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Mount Sinai School of Medicine	New York	New York
United States	Oklahoma Memorial Hospital	Oklahoma City	Oklahoma
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of California Davis Medical Center	Sacramento	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	CCOP - Florida Pediatric	Tampa	Florida
United States	CCOP - Wichita	Wichita	Kansas
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No