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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00002485
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brad H. Pollock, PhD
Principal Investigator Affiliation Pediatric Oncology Group Statistical Office
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries Canada, Puerto Rico, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

Arms

: Stratum 1

Not Enrolled / No IRB Applied

: Stratum 2

Not Enrolled / IRB Approved

Interventions

Procedure: - psychosocial assessment and care

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Address

University of California Davis Medical Center

Sacramento, California, 95817

Gainesville, Florida

Status

Address

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277

Miami, Florida

Status

Address

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136

CCOP - Florida Pediatric, Tampa, Florida

Status

Address

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757

Emory University Hospital - Atlanta, Atlanta, Georgia

Status

Address

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322

Tripler Army Medical Center, Honolulu, Hawaii

Status

Address

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000

CCOP - Wichita, Wichita, Kansas

Status

Address

CCOP - Wichita

Wichita, Kansas, 67214-3882

MBCCOP - LSU Medical Center, New Orleans, Louisiana

Status

Address

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112

Children's Hospital of Michigan, Detroit, Michigan

Status

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201

Hurley Medical Center, Flint, Michigan

Status

Address

Hurley Medical Center

Flint, Michigan, 48503

Tomorrows Children's Institute, Hackensack, New Jersey

Status

Address

Tomorrows Children's Institute

Hackensack, New Jersey, 07601

Mount Sinai School of Medicine, New York, New York

Status

Address

Mount Sinai School of Medicine

New York, New York, 10029

Memorial Mission Hospital, Asheville, North Carolina

Status

Address

Memorial Mission Hospital

Asheville, North Carolina, 28801

Presbyterian Healthcare, Charlotte, North Carolina

Status

Address

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549

Greenville, North Carolina

Status

Address

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354

Winston-Salem, North Carolina

Status

Address

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082

Oklahoma Memorial Hospital, Oklahoma City, Oklahoma

Status

Address

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307

Rhode Island Hospital, Providence, Rhode Island

Status

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425-0721

Medical City Dallas Hospital, Dallas, Texas

Status

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Baylor College of Medicine, Houston, Texas

Status

Address

Baylor College of Medicine

Houston, Texas, 77030

Lackland Air Force Base, Texas

Status

Address

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811

Vermont Cancer Center, Burlington, Vermont

Status

Address

Vermont Cancer Center

Burlington, Vermont, 05401-3498

Charleston, West Virginia

Status

Address

West Virginia University - Charleston Division

Charleston, West Virginia, 25302

Midwest Children's Cancer Center, Milwaukee, Wisconsin

Status

Address

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226

International Sites

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Montreal Children's Hospital, Montreal, Quebec, Canada

Status

Address

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3

Hopital Sainte Justine, Montreal, Quebec, Canada

Status

Address

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5

San Juan, Puerto Rico

Status

Address

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, , 00936-5067

Clinique de Pediatrie, Geneva, Switzerland

Status

Address

Clinique de Pediatrie

Geneva, , 1211