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

Primary Purpose

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
psychosocial assessment and care
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Brain and Central Nervous System Tumors focused on measuring localized osteosarcoma, metastatic osteosarcoma, recurrent childhood acute lymphoblastic leukemia, childhood infratentorial ependymoma, childhood low-grade cerebral astrocytoma, childhood supratentorial ependymoma, childhood craniopharyngioma, localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage I childhood liver cancer, stage II childhood liver cancer, stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, childhood hepatoblastoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, childhood central nervous system germ cell tumor, recurrent childhood acute myeloid leukemia, recurrent osteosarcoma, unspecified childhood solid tumor, protocol specific, childhood germ cell tumor, untreated childhood acute myeloid leukemia and other myeloid malignancies, untreated childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, extragonadal germ cell tumor, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood meningioma, localized unresectable neuroblastoma, psychosocial effects of cancer and its treatment, stage I childhood small noncleaved cell lymphoma, stage I childhood large cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage II childhood large cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage IV childhood large cell lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, untreated childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway and hypothalamic glioma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, childhood teratoma, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor, childhood atypical teratoid/rhabdoid tumor

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California Davis Medical Center
  • Shands Hospital and Clinics, University of Florida
  • Sylvester Cancer Center, University of Miami
  • CCOP - Florida Pediatric
  • Emory University Hospital - Atlanta
  • Tripler Army Medical Center
  • CCOP - Wichita
  • MBCCOP - LSU Medical Center
  • Children's Hospital of Michigan
  • Hurley Medical Center
  • Tomorrows Children's Institute
  • Mount Sinai School of Medicine
  • Memorial Mission Hospital
  • Presbyterian Healthcare
  • East Carolina University School of Medicine
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Oklahoma Memorial Hospital
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Medical City Dallas Hospital
  • Baylor College of Medicine
  • San Antonio Military Pediatric Cancer and Blood Disorders Center
  • University of Texas Health Science Center at San Antonio
  • Vermont Cancer Center
  • West Virginia University - Charleston Division
  • Midwest Children's Cancer Center
  • Children's Hospital of Eastern Ontario
  • Montreal Children's Hospital
  • Hopital Sainte Justine
  • University of Puerto Rico School of Medicine Medical Sciences Campus
  • Clinique de Pediatrie

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Stratum 1

Stratum 2

Arm Description

Not Enrolled / No IRB Applied

Not Enrolled / IRB Approved

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 12, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002485
Brief Title
Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
Official Title
Barriers to Patient Enrollment Onto Frontline Therapeutic Clinical Trials and Development of Intervention Strategies to Increase the Proportion of Enrollment
Study Type
Observational

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 1992 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
localized osteosarcoma, metastatic osteosarcoma, recurrent childhood acute lymphoblastic leukemia, childhood infratentorial ependymoma, childhood low-grade cerebral astrocytoma, childhood supratentorial ependymoma, childhood craniopharyngioma, localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage I childhood liver cancer, stage II childhood liver cancer, stage III childhood liver cancer, stage IV childhood liver cancer, recurrent childhood liver cancer, childhood hepatoblastoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, childhood central nervous system germ cell tumor, recurrent childhood acute myeloid leukemia, recurrent osteosarcoma, unspecified childhood solid tumor, protocol specific, childhood germ cell tumor, untreated childhood acute myeloid leukemia and other myeloid malignancies, untreated childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, extragonadal germ cell tumor, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood meningioma, localized unresectable neuroblastoma, psychosocial effects of cancer and its treatment, stage I childhood small noncleaved cell lymphoma, stage I childhood large cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage II childhood large cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood small noncleaved cell lymphoma, stage IV childhood large cell lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, untreated childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway and hypothalamic glioma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, childhood teratoma, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor, childhood atypical teratoid/rhabdoid tumor

7. Study Design

Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1
Arm Description
Not Enrolled / No IRB Applied
Arm Title
Stratum 2
Arm Description
Not Enrolled / IRB Approved
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Primary Outcome Measure Information:
Title
Determine why eligible patients are not enrolled on available Pediatric Oncology Group therapeutic clinical trials.
Description
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad H. Pollock, PhD
Organizational Affiliation
Pediatric Oncology Group Statistical Office
Official's Role
Study Chair
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Shands Hospital and Clinics, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
CCOP - Florida Pediatric
City
Tampa
State/Province
Florida
ZIP/Postal Code
33682-7757
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
MBCCOP - LSU Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Tomorrows Children's Institute
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Presbyterian Healthcare
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
East Carolina University School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858-4354
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Oklahoma Memorial Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73126-0307
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Antonio Military Pediatric Cancer and Blood Disorders Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236-5300
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
West Virginia University - Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
University of Puerto Rico School of Medicine Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Clinique de Pediatrie
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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