Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
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|ClinicalTrials.gov Identifier: NCT00002485|
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : February 14, 2014
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|
|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|
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 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 :||February 1992|
|Primary Completion Date :||July 2003|
|Study Completion Date :||September 2005|
Not Enrolled / No IRB Applied
|Procedure: psychosocial assessment and care|
Not Enrolled / IRB Approved
|Procedure: psychosocial assessment and care|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002485
Show 31 Study Locations
|Study Chair:||Brad H. Pollock, PhD||Pediatric Oncology Group Statistical Office|