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

NCT00002485CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Children's Oncology Group

Enrollment

359

Start Date

1992-02-01

Completion Date

2003-07-01

Study Type

OBSERVATIONAL

Official Title

Barriers to Patient Enrollment Onto Frontline Therapeutic Clinical Trials and Development of Intervention Strategies to Increase the Proportion of Enrollment

Interventions

psychosocial assessment and care

Conditions

Brain and Central Nervous System TumorsChildhood Germ Cell TumorExtragonadal Germ Cell TumorLeukemiaLiver CancerLymphomaNeuroblastomaOvarian CancerPsychosocial Effects of Cancer and Its TreatmentSarcomaUnspecified Childhood Solid TumorProtocol Specific

Eligibility

Sex

ALL

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

Outcome Measures

Primary Outcomes

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.

Locations

University of California Davis Medical Center, Sacramento, United States

Shands Hospital and Clinics, University of Florida, Gainesville, United States

Sylvester Cancer Center, University of Miami, Miami, United States

CCOP - Florida Pediatric, Tampa, United States

Emory University Hospital - Atlanta, Atlanta, United States

Tripler Army Medical Center, Honolulu, United States

CCOP - Wichita, Wichita, United States

MBCCOP - LSU Medical Center, New Orleans, United States

Children's Hospital of Michigan, Detroit, United States

Hurley Medical Center, Flint, United States

Tomorrows Children's Institute, Hackensack, United States

Mount Sinai School of Medicine, New York, United States

Memorial Mission Hospital, Asheville, United States

Presbyterian Healthcare, Charlotte, United States

East Carolina University School of Medicine, Greenville, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, United States

Oklahoma Memorial Hospital, Oklahoma City, United States

Rhode Island Hospital, Providence, United States

Medical University of South Carolina, Charleston, United States

Medical City Dallas Hospital, Dallas, United States

Baylor College of Medicine, Houston, United States

San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, United States

University of Texas Health Science Center at San Antonio, San Antonio, United States

Vermont Cancer Center, Burlington, United States

West Virginia University - Charleston Division, Charleston, United States

Midwest Children's Cancer Center, Milwaukee, United States

Children's Hospital of Eastern Ontario, Ottawa, Canada

Montreal Children's Hospital, Montreal, Canada

Hopital Sainte Justine, Montreal, Canada

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, Puerto Rico

Clinique de Pediatrie, Geneva, Switzerland