Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002485
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Barriers to Patient Enrollment Onto Frontline Therapeutic Clinical Trials and Development of Intervention Strategies to Increase the Proportion of Enrollment
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Patientsparents on stratum 2 who refused enrollment and their primary physicians complete questionnaires that address reasons for nonenrollment Control patientsparents 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 Hodgkins disease 60 with non-Hodgkins 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
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 Patientsparents on stratum 2 who refused enrollment and their primary physicians complete questionnaires that address reasons for nonenrollment Control patientsparents 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 Hodgkins disease 60 with non-Hodgkins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| POG-92849285 | OTHER | None | None |
| NCI-P92-0003 | None | None | None |
| CDR0000077305 | OTHER | Clinicaltrialsgov | None |