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

NCT00002485 | Completed

• 4 other identifiers: 9284POG-9284/9285NCI-P92-0003CDR0000077305
• Study Type: observational
• Target: 359
• Locations: 4 countries
• Sites: 31

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.

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; 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

Outcome Measures

Primary Outcomes (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.

Study Arms (2)

Stratum 1

Not Enrolled / No IRB Applied

Procedure: psychosocial assessment and care

Stratum 2

Not Enrolled / IRB Approved

Procedure: psychosocial assessment and care

Interventions

psychosocial assessment and care PROCEDURE

Stratum 1; Stratum 2

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (31)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Tomorrows Children's Institute

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Memorial Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

West Virginia University - Charleston Division

Charleston, West Virginia, 25302, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Leukemia; Liver Neoplasms; Lymphoma; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Osteosarcoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hepatoblastoma; Recurrence; Astrocytoma; Oligodendroglioma; Choroid Plexus Neoplasms; Meningioma; Burkitt Lymphoma; Dendritic Cell Sarcoma, Interdigitating; Medulloblastoma; Optic Nerve Glioma; Familial ependymoma; Teratoma; Testicular Neoplasms; Ovarian Germ Cell Cancer; Rhabdoid Tumor

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Leukemia, Lymphoid; Neoplasms, Complex and Mixed; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Histiocytic Disorders, Malignant; Histiocytosis; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brad H. Pollock, PhD

  Pediatric Oncology Group Statistical Office

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 26, 2004
• Study Start: February 1, 1992
• Primary Completion: July 1, 2003
• Study Completion: September 1, 2005
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

CA (3); CH (1); PR (1); US (26)