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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002485

Collaborator

National Cancer Institute (NCI) (NIH)

359

Enrollment

Locations

163

Duration (Months)

11.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Leukemia Liver Cancer Lymphoma Neuroblastoma Ovarian Cancer Psychosocial Effects of Cancer and Its Treatment Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific	Procedure: psychosocial assessment and care

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 Design

Study Type:

Observational

Actual Enrollment :

359 participants

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 :

Feb 1, 1992

Actual Primary Completion Date :

Jul 1, 2003

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Stratum 1 Not Enrolled / No IRB Applied	Procedure: psychosocial assessment and care
Stratum 2 Not Enrolled / IRB Approved	Procedure: psychosocial assessment and care

Arm

Intervention/Treatment

Stratum 1

Not Enrolled / No IRB Applied

Procedure: psychosocial assessment and care

Stratum 2

Not Enrolled / IRB Approved

Procedure: psychosocial assessment and care

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis Medical Center	Sacramento	California	United States	95817
2	Shands Hospital and Clinics, University of Florida	Gainesville	Florida	United States	32610-100277
3	Sylvester Cancer Center, University of Miami	Miami	Florida	United States	33136
4	CCOP - Florida Pediatric	Tampa	Florida	United States	33682-7757
5	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
6	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859-5000
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	MBCCOP - LSU Medical Center	New Orleans	Louisiana	United States	70112
9	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
10	Hurley Medical Center	Flint	Michigan	United States	48503
11	Tomorrows Children's Institute	Hackensack	New Jersey	United States	07601
12	Mount Sinai School of Medicine	New York	New York	United States	10029
13	Memorial Mission Hospital	Asheville	North Carolina	United States	28801
14	Presbyterian Healthcare	Charlotte	North Carolina	United States	28233-3549
15	East Carolina University School of Medicine	Greenville	North Carolina	United States	27858-4354
16	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
17	Oklahoma Memorial Hospital	Oklahoma City	Oklahoma	United States	73126-0307
18	Rhode Island Hospital	Providence	Rhode Island	United States	02903
19	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
20	Medical City Dallas Hospital	Dallas	Texas	United States	75230
21	Baylor College of Medicine	Houston	Texas	United States	77030
22	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas	United States	78236-5300
23	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811
24	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
25	West Virginia University - Charleston Division	Charleston	West Virginia	United States	25302
26	Midwest Children's Cancer Center	Milwaukee	Wisconsin	United States	53226
27	Children's Hospital of Eastern Ontario	Ottawa	Ontario	Canada	K1H 8L1
28	Montreal Children's Hospital	Montreal	Quebec	Canada	H3H 1P3
29	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
30	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan		Puerto Rico	00936-5067
31	Clinique de Pediatrie	Geneva		Switzerland	1211