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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific; Leukemia; Ovarian Cancer; Brain and Central Nervous System Tumors; Neuroblastoma; Liver Cancer; Psychosocial Effects of Cancer and Its Treatment; Extragonadal Germ Cell Tumor; Childhood Germ Cell Tumor
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 359

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
  • Quebec
    • Montreal, Quebec, Canada, H3H 1P3
      • Montreal Children's Hospital
    • Montreal, Quebec, Canada, H3T 1C5
      • Hopital Sainte Justine
• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico School of Medicine Medical Sciences Campus
• Switzerland
  • Geneva, Switzerland, 1211
    • Clinique de Pediatrie
• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610-100277
      • Shands Hospital and Clinics, University of Florida
    • Miami, Florida, United States, 33136
      • Sylvester Cancer Center, University of Miami
    • Tampa, Florida, United States, 33682-7757
      • CCOP - Florida Pediatric
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - Atlanta
  • Hawaii
    • Honolulu, Hawaii, United States, 96859-5000
      • Tripler Army Medical Center
  • Kansas
    • Wichita, Kansas, United States, 67214-3882
      • CCOP - Wichita
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Tomorrows Children's Institute
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Memorial Mission Hospital
    • Charlotte, North Carolina, United States, 28233-3549
      • Presbyterian Healthcare
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University School of Medicine
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73126-0307
      • Oklahoma Memorial Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Lackland Air Force Base, Texas, United States, 78236-5300
      • San Antonio Military Pediatric Cancer and Blood Disorders Center
    • San Antonio, Texas, United States, 78284-7811
      • University of Texas Health Science Center at San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • West Virginia University - Charleston Division
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Midwest Children's Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

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.

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Brad H. Pollock, PhD, Pediatric Oncology Group Statistical Office

Study record dates

Study Major Dates

• Study Start: February 1, 1992
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: April 23, 2004
• First Posted (Estimate): April 26, 2004

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: unspecified childhood solid tumor, protocol specific; untreated childhood brain stem glioma; childhood high-grade cerebral astrocytoma; stage III childhood small noncleaved 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; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; untreated childhood acute lymphoblastic leukemia; recurrent/refractory childhood Hodgkin lymphoma; psychosocial effects of cancer and its treatment; localized osteosarcoma; disseminated neuroblastoma; localized unresectable neuroblastoma; recurrent neuroblastoma; stage 4S neuroblastoma; recurrent childhood acute lymphoblastic leukemia; stage I childhood large cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage I childhood lymphoblastic lymphoma; stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood small noncleaved cell lymphoma; regional neuroblastoma; untreated childhood medulloblastoma; untreated childhood cerebellar astrocytoma; childhood infratentorial ependymoma; newly diagnosed childhood ependymoma; childhood atypical teratoid/rhabdoid tumor; stage IV childhood Hodgkin lymphoma; recurrent childhood acute myeloid leukemia; recurrent childhood lymphoblastic lymphoma; stage III childhood Hodgkin lymphoma; metastatic osteosarcoma; recurrent osteosarcoma; stage I childhood Hodgkin lymphoma; stage II childhood Hodgkin lymphoma; childhood supratentorial ependymoma; childhood oligodendroglioma; recurrent childhood supratentorial primitive neuroectodermal tumor; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood ependymoma; extragonadal germ cell tumor; stage IV childhood liver cancer; recurrent childhood liver cancer; metastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; recurrent childhood brain stem glioma; recurrent childhood medulloblastoma; recurrent childhood visual pathway and hypothalamic glioma; childhood craniopharyngioma; childhood central nervous system germ cell tumor; childhood germ cell tumor; childhood choroid plexus tumor; 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; untreated childhood acute myeloid leukemia and other myeloid malignancies; nonmetastatic childhood soft tissue sarcoma; localized resectable neuroblastoma; childhood low-grade cerebral astrocytoma; untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood visual pathway and hypothalamic glioma; stage I childhood liver cancer; stage II childhood liver cancer; stage III childhood liver cancer; childhood hepatoblastoma; childhood meningioma
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms; Sarcoma; Lymphoma; Neoplasms, Germ Cell and Embryonal; Leukemia; Nervous System Neoplasms; Central Nervous System Neoplasms; Liver Neoplasms; Neuroblastoma
• Other Study ID Numbers: 9284; POG-9284/9285 (Other Identifier: Pediatric Oncology Group); NCI-P92-0003; CDR0000077305 (Other Identifier: Clinicaltrials.gov)