Brain and Central Nervous System TumorsNCT00002485
Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
An observational study of Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Children's Oncology Group at 31 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor
- What is being tested?
- psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 359 participants
- Where
- 31 sitesin 4 countries
- Study dates
- Feb 1992to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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 locations and contacts
31 sites in 4 countries.
31 sites in 4 countries
United States26 sites
Memorial Mission Hospital
Asheville, North Carolina, 28801
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
West Virginia University - Charleston Division
Charleston, West Virginia, 25302
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
Medical City Dallas Hospital
Dallas, Texas, 75230
Children's Hospital of Michigan
Detroit, Michigan, 48201
Hurley Medical Center
Flint, Michigan, 48503
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
Tomorrows Children's Institute
Hackensack, New Jersey, 07601
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
Baylor College of Medicine
Houston, Texas, 77030
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
Mount Sinai School of Medicine
New York, New York, 10029
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California Davis Medical Center
Sacramento, California, 95817
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
CCOP - Wichita
Wichita, Kansas, 67214-3882
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
Canada3 sites
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Puerto Rico1 site
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Leukemia, Liver Cancer, Lymphoma
- Being tested
- psychosocial assessment and care
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Leukemia, Liver Neoplasms, Lymphoma, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Not Enrolled / No IRB Applied Receives: Procedure: psychosocial assessment and care | |
| Stratum 2 | Not Enrolled / IRB Approved Receives: Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2004 (estimated)
- Study startFeb 1992
- Primary completionJul 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brad H. Pollock, PhD, Study chair, Pediatric Oncology Group Statistical Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002485
- Sponsor's protocol ID
- 9284
- Other IDs
- POG-9284/9285, NCI-P92-0003, CDR0000077305
- Status last verified
- Feb 2014
- First submitted
- 1 Nov 1999
- Last updated
- 14 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Patient Enrollment Onto Frontline Therapeutic Clinical Trials and Development of Intervention Strategies to Increase the Proportion of Enrollment
- ClinicalTrials.gov ID
- NCT00002485
- Acronym / sponsor ID
- 9284
- Conditions
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Leukemia, Liver Cancer, Lymphoma
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1992
- Primary completion
- Jul 2003 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 26 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | – | Procedure: psychosocial assessment and careNot Enrolled / No IRB Applied |
| Stratum 2 | – | Procedure: psychosocial assessment and careNot Enrolled / IRB Approved |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | Stratum 1, Stratum 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad H. Pollock, PhD study chair
Pediatric Oncology Group Statistical Office
31 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Children's Oncology Group at 31 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Puerto Rico, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine why eligible patients are not enrolled on available Pediatric Oncology Group therapeutic clinical trials.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014; AzTrials last refreshed its copy on 26 Oct 2026.