Development of Strategies to Increase Enrollment in Clini... | NCT00002485 | Trialant
NCT00002485
Sponsor
Children's Oncology Group
Status
Completed
Last Update Posted
Feb 14, 2014Estimated
Enrollment
359Actual
Phase
Not provided
Conditions
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
Interventions
psychosocial assessment and care
Countries
United States
Canada
Puerto Rico
Switzerland
Protocol Section
Identification Module
NCT ID
NCT00002485
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
9284
Secondary IDs
ID
Type
Description
Link
POG-9284/9285
Other Identifier
Pediatric Oncology Group
NCI-P92-0003
CDR0000077305
Other Identifier
Clinicaltrials.gov
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
Acronym
Not provided
Organization
Children's Oncology GroupNETWORK
Status Module
Record Verification Date
Feb 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1992
Primary Completion Date
Jul 2003Actual
Completion Date
Sep 2005Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Apr 23, 2004
First Posted Date
Apr 26, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 12, 2014
Last Update Posted Date
Feb 14, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Children's Oncology GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
359Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stratum 1
Not Enrolled / No IRB Applied
Procedure: psychosocial assessment and care
Stratum 2
Not Enrolled / IRB Approved
Procedure: psychosocial assessment and care
Interventions
Name
Type
Description
Arm Group Labels
Other Names
psychosocial assessment and care
Procedure
Stratum 1
Stratum 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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 Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
21 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Brad H. Pollock, PhD
Pediatric Oncology Group Statistical Office
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California Davis Medical Center
Sacramento
California
95817
United States
Shands Hospital and Clinics, University of Florida
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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