Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-09 @ 4:11 PM
Study NCT ID:
NCT00678002
Status:
TERMINATED
Last Update Posted:
2020-11-30
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Pediatric Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2008-05-12', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'every 6 months'}], 'secondaryOutcomes': [{'measure': 'Peds QL Family Impact Module', 'timeFrame': 'every 6 months'}, {'measure': 'Peds QL Family Information Form', 'timeFrame': 'every 6 months'}, {'measure': 'Functional Status II-R', 'timeFrame': 'every 6 months'}, {'measure': 'Child Vulnerability Scale', 'timeFrame': 'every 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['solid organ transplant'], 'conditions': ['Kidney Transplantation', 'Liver Transplantation', 'Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '15176957', 'type': 'BACKGROUND', 'citation': 'Cole CR, Bucuvalas JC, Hornung RW, Krug S, Ryckman FC, Atherton H, Alonso MP, Balistreri WF, Kotagal U. Impact of liver transplantation on HRQOL in children less than 5 years old. Pediatr Transplant. 2004 Jun;8(3):222-7. doi: 10.1111/j.1399-3046.2004.00126.x.'}, {'pmid': '8820075', 'type': 'BACKGROUND', 'citation': 'Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. doi: 10.1093/jpepsy/21.1.89.'}, {'pmid': '15261181', 'type': 'BACKGROUND', 'citation': 'Freier MC, Babikian T, Pivonka J, Burley Aaen T, Gardner JM, Baum M, Bailey LL, Chinnock RE. A longitudinal perspective on neurodevelopmental outcome after infant cardiac transplantation. J Heart Lung Transplant. 2004 Jul;23(7):857-64. doi: 10.1016/j.healun.2003.08.003.'}, {'pmid': '16703376', 'type': 'BACKGROUND', 'citation': 'Goldstein SL, Graham N, Burwinkle T, Warady B, Farrah R, Varni JW. Health-related quality of life in pediatric patients with ESRD. Pediatr Nephrol. 2006 Jun;21(6):846-50. doi: 10.1007/s00467-006-0081-y. Epub 2006 Apr 20.'}, {'pmid': '17944159', 'type': 'BACKGROUND', 'citation': "Green A, McSweeney J, Ainley K, Bryant J. In my shoes: children's quality of life after heart transplantation. Prog Transplant. 2007 Sep;17(3):199-207; quiz 208. doi: 10.1177/152692480701700307."}, {'pmid': '12756049', 'type': 'BACKGROUND', 'citation': "Manificat S, Dazord A, Cochat P, Morin D, Plainguet F, Debray D. Quality of life of children and adolescents after kidney or liver transplantation: child, parents and caregiver's point of view. Pediatr Transplant. 2003 Jun;7(3):228-35. doi: 10.1034/j.1399-3046.2003.00065.x."}, {'pmid': '15934713', 'type': 'BACKGROUND', 'citation': 'Mussatto K, Tweddell J. Quality of life following surgery for congenital cardiac malformations in neonates and infants. Cardiol Young. 2005 Feb;15 Suppl 1:174-8. doi: 10.1017/s1047951105001253. No abstract available.'}, {'pmid': '14611988', 'type': 'BACKGROUND', 'citation': 'Pollock-BarZiv SM, Anthony SJ, Niedra R, Dipchand AI, West LJ. Quality of life and function following cardiac transplantation in adolescents. Transplant Proc. 2003 Nov;35(7):2468-70. doi: 10.1016/j.transproceed.2003.08.028.'}, {'type': 'BACKGROUND', 'citation': 'Roy, C., & Andrews, H. A. (1991). The roy adaptation model: The definitive statement. East Norwalk, Connecticut: Prentice Hall.'}, {'pmid': '12717209', 'type': 'BACKGROUND', 'citation': 'Schulz KH, Wein C, Boeck A, Rogiers X, Burdelski M. Cognitive performance of children who have undergone liver transplantation. Transplantation. 2003 Apr 27;75(8):1236-40. doi: 10.1097/01.TP.0000062843.10397.32.'}, {'pmid': '8140186', 'type': 'BACKGROUND', 'citation': 'Stuber ML. Psychiatric aspects of organ transplantation in children and adolescents. Psychosomatics. 1993 Sep-Oct;34(5):379-87. doi: 10.1016/S0033-3182(93)71840-X.'}, {'pmid': '16613592', 'type': 'BACKGROUND', 'citation': 'Sweet SC, Wong HH, Webber SA, Horslen S, Guidinger MK, Fine RN, Magee JC. Pediatric transplantation in the United States, 1995-2004. Am J Transplant. 2006;6(5 Pt 2):1132-52. doi: 10.1111/j.1600-6143.2006.01271.x.'}, {'pmid': '11468499', 'type': 'BACKGROUND', 'citation': 'Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.'}, {'pmid': '15450120', 'type': 'BACKGROUND', 'citation': 'Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.'}, {'pmid': '15454178', 'type': 'BACKGROUND', 'citation': 'Wray J, Radley-Smith R. Depression in pediatric patients before and 1 year after heart or heart-lung transplantation. J Heart Lung Transplant. 2004 Sep;23(9):1103-10. doi: 10.1016/j.healun.2003.08.018.'}, {'pmid': '16507430', 'type': 'BACKGROUND', 'citation': 'Wray J, Radley-Smith R. Longitudinal assessment of psychological functioning in children after heart or heart-lung transplantation. J Heart Lung Transplant. 2006 Mar;25(3):345-52. doi: 10.1016/j.healun.2005.09.018. Epub 2006 Jan 18.'}, {'pmid': '15787788', 'type': 'BACKGROUND', 'citation': 'Wray J, Radley-Smith R. Beyond the first year after pediatric heart or heart-lung transplantation: Changes in cognitive function and behaviour. Pediatr Transplant. 2005 Apr;9(2):170-7. doi: 10.1111/j.1399-3046.2005.00265.x.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.', 'detailedDescription': 'There are numerous studies that report on the quality of life in solid organ transplant recipients. However, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. Furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations.\n\nThe goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions. Outcomes will be measured by using five different instruments:\n\n1. Pediatric Quality of Life Inventory (PedsQL)\n2. PedsQL Family Impact Module\n3. PedsQL Family Information Form\n4. Functional Status II-R\n5. Child Vulnerability Scale (CVS)\n\nPatients will be enrolled at the time of transplant listing, or after transplant. Patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. After transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter.\n\nThis study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. The results may also indicate trend differences between these three populations. These differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children's Hospital of Wisconsin in the Hepatology Clinic, Cardiology Clinic, and Kidney Clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between newborn and 21 years old\n* parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant\n\nExclusion Criteria:\n\n* unwilling or unable to participate\n* not in one of the above transplant groups\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT00678002', 'briefTitle': 'Quality of Life in Pediatric Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients', 'orgStudyIdInfo': {'id': 'CHW 08/157'}, 'secondaryIdInfos': [{'id': 'GC173'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'QOL###', 'description': 'All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Stacee Lerret, CPNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}, {'name': 'Gail Stendahl, CPNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Health System Foundation, Wisconsin"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Advanced Practice Nurse', 'investigatorFullName': 'Stacee Lerret', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}