title: Feasibility of conducting long-term follow-up of children and infants treated for CNS tumors on the same cooperative group clinical trial protocol.
abstract: Given the barriers to conducting long-term assessment of neurocognitive and psychosocial functioning of those treated in infancy for central nervous system (CNS) tumors, a multi-site feasibility study was conducted. The primary objective was to demonstrate that it is feasible to identify, locate and assess the functioning of children treated on the same protocol 10-years post-treatment. Six sites obtained institutional approval, identified and recruited subjects, and obtained comprehensive neurocognitive and psychosocial data. All feasibility objectives were met. Barriers to participation included length of time for Institutional Review Board submission and review, clinical demands, limited eligible participants at individual institutions, difficulty locating long-term subjects and stipend/reimbursement concerns. Results indicate that long-term studies are feasible and essential given the need to address long-term issues of children treated at a young age for CNS tumors, especially as they relate to later academic and vocational planning, but require significant coordination and commitment of cooperative group and institutional resources.
authors.affiliation: Department of Pediatrics, Hematology/Oncology/Bone Marrow Transplant, Medical College of Wisconsin, 8701 Watertown Plank Road, MFRC 3018, Milwaukee, WI, 53226, USA, jhoag@mcw.edu.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Hoag
authors.forename: Mary Jo
authors.initials: MJ
authors.lastname: Kupst
authors.forename: Marie-Eve
authors.initials: ME
authors.lastname: Briere
authors.forename: Donald
authors.initials: D
authors.lastname: Mabbott
authors.forename: T David
authors.initials: TD
authors.lastname: Elkin
authors.forename: Christine L
authors.initials: CL
authors.lastname: Trask
authors.forename: Jill
authors.initials: J
authors.lastname: Isenberg
authors.forename: Suzanne
authors.initials: S
authors.lastname: Holm
authors.forename: Cheryl
authors.initials: C
authors.lastname: Ambler
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Strother
mesh_terms: D000293:Adolescent; D016543:Central Nervous System Neoplasms / Q000523:psychology* / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D003299:Cooperative Behavior; D003625:Data Collection / Q000379:methods*; D004522:Educational Status; D056344:Executive Function / Q000502:physiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007360:Intelligence / Q000502:physiology; D008297:Male; D008568:Memory / Q000502:physiology; D008603:Mental Health / Q000706:statistics & numerical data*; D008606:Mental Processes / Q000502:physiology; D010349:Patient Compliance / Q000706:statistics & numerical data*; D016896:Treatment Outcome