Neuropsychological and Behavioral Testing in Younger Patients With Cancer
Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT00772200
Collaborator
National Cancer Institute (NCI) (NIH)
1,200
184
6.5
Study Details
Study Description
Brief Summary
This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
- To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points.
OUTLINE:
Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
Actual Study Start Date
:
Sep 15, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (neuropsychological and behavioral tests) Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life. |
Procedure: Cognitive Assessment
Complete COG Standard Neuropsychological and Behavioral Battery
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Compliance rate for completion of neuropsychological and behavioral battery [Up to 72 months post-diagnosis]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Month
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
-
The patient must have receptive and expressive language skills in English, French, or Spanish; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
-
All patients and/or their parents or legal guardians must sign a written informed consent
-
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with a history of moderate to profound intellectual disability (i.e. intelligence quotient [IQ] =< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 3 | Cardon Children's Medical Center | Mesa | Arizona | United States | 85202 |
| 4 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
| 5 | Kaiser Permanente Downey Medical Center | Downey | California | United States | 90242 |
| 6 | Miller Children's and Women's Hospital Long Beach | Long Beach | California | United States | 90806 |
| 7 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 8 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 9 | Mattel Children's Hospital UCLA | Los Angeles | California | United States | 90095 |
| 10 | Valley Children's Hospital | Madera | California | United States | 93636 |
| 11 | Children's Hospital and Research Center at Oakland | Oakland | California | United States | 94609-1809 |
| 12 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 13 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 14 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 15 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
| 16 | UCSF Medical Center-Parnassus | San Francisco | California | United States | 94143 |
| 17 | UCSF Medical Center-Mission Bay | San Francisco | California | United States | 94158 |
| 18 | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | United States | 90502 |
| 19 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 20 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 21 | Yale University | New Haven | Connecticut | United States | 06520 |
| 22 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 23 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 24 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 25 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 26 | Lee Memorial Health System | Fort Myers | Florida | United States | 33901 |
| 27 | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 28 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 29 | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 30 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 31 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 32 | Nicklaus Children's Hospital | Miami | Florida | United States | 33155 |
| 33 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 34 | Arnold Palmer Hospital for Children | Orlando | Florida | United States | 32806 |
| 35 | Nemours Children's Clinic - Orlando | Orlando | Florida | United States | 32806 |
| 36 | UF Cancer Center at Orlando Health | Orlando | Florida | United States | 32806 |
| 37 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 38 | Nemours Children's Clinic - Pensacola | Pensacola | Florida | United States | 32504 |
| 39 | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 40 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 41 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 42 | Saint Mary's Hospital | West Palm Beach | Florida | United States | 33407 |
| 43 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 44 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 45 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 46 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 47 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 48 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60611 |
| 49 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 50 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 51 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 52 | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | United States | 60453 |
| 53 | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | United States | 60068 |
| 54 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 55 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 56 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 57 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 58 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 59 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 60 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 61 | Norton Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 62 | Children's Hospital New Orleans | New Orleans | Louisiana | United States | 70118 |
| 63 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 64 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 65 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 66 | Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 67 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 68 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 69 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 70 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 71 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 72 | Michigan State University Clinical Center | East Lansing | Michigan | United States | 48824-7016 |
| 73 | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 74 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 75 | Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | United States | 49008 |
| 76 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 77 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 78 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 79 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 80 | Children's Mercy Hospitals and Clinics | Kansas City | Missouri | United States | 64108 |
| 81 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 82 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 83 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 84 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 85 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
| 86 | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | United States | 89135 |
| 87 | Summerlin Hospital Medical Center | Las Vegas | Nevada | United States | 89144 |
| 88 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 89 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 90 | Saint Barnabas Medical Center | Livingston | New Jersey | United States | 07039 |
| 91 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 92 | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
| 93 | Newark Beth Israel Medical Center | Newark | New Jersey | United States | 07112 |
| 94 | Saint Joseph's Regional Medical Center | Paterson | New Jersey | United States | 07503 |
| 95 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 96 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 97 | Albany Medical Center | Albany | New York | United States | 12208 |
| 98 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 99 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 100 | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | United States | 11040 |
| 101 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 102 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 103 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 104 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 105 | University of Rochester | Rochester | New York | United States | 14642 |
| 106 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 107 | New York Medical College | Valhalla | New York | United States | 10595 |
| 108 | Mission Hospital | Asheville | North Carolina | United States | 28801 |
| 109 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 110 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 111 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 112 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 113 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 114 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 115 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 116 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 117 | Rainbow Babies and Childrens Hospital | Cleveland | Ohio | United States | 44106 |
| 118 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 119 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 120 | Dayton Children's Hospital | Dayton | Ohio | United States | 45404 |
| 121 | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | United States | 43606 |
| 122 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 123 | Legacy Emanuel Children's Hospital | Portland | Oregon | United States | 97227 |
| 124 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 125 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 126 | Penn State Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
| 127 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 128 | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | United States | 19134 |
| 129 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 130 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 131 | Prisma Health Richland Hospital | Columbia | South Carolina | United States | 29203 |
| 132 | BI-LO Charities Children's Cancer Center | Greenville | South Carolina | United States | 29605 |
| 133 | Greenville Cancer Treatment Center | Greenville | South Carolina | United States | 29605 |
| 134 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 135 | T C Thompson Children's Hospital | Chattanooga | Tennessee | United States | 37403 |
| 136 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 137 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 138 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 139 | Dell Children's Medical Center of Central Texas | Austin | Texas | United States | 78723 |
| 140 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 141 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 142 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 143 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
| 144 | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | United States | 77030 |
| 145 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 146 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 147 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 148 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 149 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 150 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 151 | University of Vermont and State Agricultural College | Burlington | Vermont | United States | 05405 |
| 152 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 153 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 154 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 155 | Carilion Clinic Children's Hospital | Roanoke | Virginia | United States | 24014 |
| 156 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 157 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 158 | West Virginia University Charleston Division | Charleston | West Virginia | United States | 25304 |
| 159 | West Virginia University Healthcare | Morgantown | West Virginia | United States | 26506 |
| 160 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 161 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 162 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 163 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 164 | John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales | Australia | 2310 |
| 165 | Sydney Children's Hospital | Randwick | New South Wales | Australia | 2031 |
| 166 | The Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 167 | Royal Children's Hospital-Brisbane | Herston | Queensland | Australia | 4029 |
| 168 | Queensland Children's Hospital | South Brisbane | Queensland | Australia | 4101 |
| 169 | Women's and Children's Hospital-Adelaide | North Adelaide | South Australia | Australia | 5006 |
| 170 | Royal Children's Hospital | Parkville | Victoria | Australia | 3052 |
| 171 | Princess Margaret Hospital for Children | Perth | Western Australia | Australia | 6008 |
| 172 | Perth Children's Hospital | Perth | Western Australia | Australia | 6009 |
| 173 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
| 174 | British Columbia Children's Hospital | Vancouver | British Columbia | Canada | V6H 3V4 |
| 175 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 176 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 177 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N 3Z5 |
| 178 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 179 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 180 | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 181 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 182 | Starship Children's Hospital | Grafton | Auckland | New Zealand | 1145 |
| 183 | Christchurch Hospital | Christchurch | New Zealand | 8011 | |
| 184 | University Pediatric Hospital | San Juan | Puerto Rico | 00926 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Leanne M Embry, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00772200
Other Study ID Numbers:
- ALTE07C1
- NCI-2009-00383
- CDR0000594326
- COG-ALTE07C1
- ALTE07C1
- ALTE07C1
- U10CA180886
- U10CA098543
- UG1CA189955
- UG1CA189958
First Posted:
Oct 15, 2008
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms: