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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002485
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : February 14, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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
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.

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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
Actual Primary Completion Date : July 2003
Actual Study Completion Date : September 2005

Group/Cohort 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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002485

Show Show 31 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Study Chair: Brad H. Pollock, PhD Pediatric Oncology Group Statistical Office
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Responsible Party: Children's Oncology Group Identifier: NCT00002485    
Other Study ID Numbers: 9284
POG-9284/9285 ( Other Identifier: Pediatric Oncology Group )
CDR0000077305 ( Other Identifier: )
First Posted: April 26, 2004    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by Children's Oncology Group:
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
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Nervous System Diseases