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



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

For Condition: childhood solid tumor,childhood acute lymphoblastic leukemia,psychosocial effects/treatment,childhood acute myeloid leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: 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.
Details: OBJECTIVES: I. Identify prospectively physician and patient factors associated with reasons why patients who are eligible for therapeutic protocols made available through the Pediatric Oncology Group 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 the number of enrollments to therapeutic protocols for patients for whom a protocol is available. PROTOCOL OUTLINE: Nonrandomized study. Assessment of Barriers to Protocol Enrollment. Questionnaires completed by physician and patient and/or parent. PROJECTED ACCRUAL: It is expected that, over a 7-year period, the following number of cancer patients refusing enrollment on a clinical trial will be accrued: 12 soft tissue sarcoma, 34 bone, 19 brain, 32 Hodgkin's disease, 60 NHL, 278 ALL, 65 ANLL, 56 neuroblastoma, 14 hepatoblastoma, and 25 germ cell.
Eligibility:
Study Type:
  Observational, Cross-Sectional
Minimum Age/Maximum Age: /21 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Population Characteristics-- - Case or control patients aged 21 and under clinically eligible for registration on a POG frontline therapeutic protocol (whether or not the protocol was submitted to or approved by the physician's IRB): Cases are patients who have not enrolled on the POG frontline protocol (decision made by physician or patient/parent); Controls are patients who have been enrolled on the POG frontline protocol; Patients offered treatment on an in-house therapeutic protocol (IRB-approved) rather than the POG protocol are ineligible as either cases or controls
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BradPollock,  Study Chair,  Pediatric Oncology Group

Oklahoma Memorial Hospital
Oklahoma City,  Oklahoma,  73126-0307
United States
 

Rhode Island Hospital
Providence,  Rhode Island,  02903
United States
 

San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base,  Texas,  78236-5300
United States
 

Tripler Army Medical Center
Honolulu,  Hawaii,  96859-5000
United States
 

East Carolina University School of Medicine
Greenville,  North Carolina,  27858-4354
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7811
United States
 

University of California Davis Medical Center
Sacramento,  California,  95817
United States
 

Mount Sinai School of Medicine
New York City,  New York,  10029
United States
 

Hopital Sainte Justine
Montreal,  Quebec,  H3T 1C5
Canada
 

Medical City Dallas Hospital
Dallas,  Texas,  75230
United States
 

Montreal Children's Hospital
Montreal,  Quebec,  H3H 1P3
Canada
 

Presbyterian Healthcare
Charlotte,  North Carolina,  28233-3549
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

Children's Hospital of Eastern Ontario
Ottawa,  Ontario,  K1H 8L1
Canada
 

Children's Hospital of Michigan
Detroit,  Michigan,  48201
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Hurley Medical Center
Flint,  Michigan,  48503
United States
 

Sylvester Cancer Center, University of Miami
Miami,  Florida,  33136
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

Midwest Children's Cancer Center
Milwaukee,  Wisconsin,  53226
United States
 

Clinique de Pediatrie
Geneva,  ,  1211
Switzerland
 

Tomorrows Children's Institute
Hackensack,  New Jersey,  07601
United States
 

MBCCOP - LSU Medical Center
New Orleans,  Louisiana,  70112
United States
 

West Virginia University - Charleston Division
Charleston,  West Virginia,  25302
United States
 

Shands Hospital and Clinics, University of Florida
Gainesville,  Florida,  32610-100277
United States
 

CCOP - Florida Pediatric
Tampa,  Florida,  33682-7757
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 

University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan,  ,  00936-5067
Puerto Rico
 

Memorial Mission Hospital
Asheville,  North Carolina,  28801
United States
 

Vermont Cancer Center
Burlington,  Vermont,  05401-3498
United States
 


Additional Information:
Study ID Numbers:
  CDR0000077305;  POG-9284/9285,NCI-P92-0003
Study Start Date: February 1992
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002485

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4. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

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