Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-29 @ 10:45 AM
Study NCT ID:
NCT00872833
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2009-03-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'egerstenberger@neriscience.com', 'phone': '6179237747', 'title': 'Eric Gerstenberger', 'organization': 'New England Research Institutes, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse event data were not collected for this observational study', 'eventGroups': [{'id': 'EG000', 'title': 'Adverse Events Were Not Collected', 'description': 'Adverse events were not collected as part of this observational study.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Report of Pain by Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Participant-cycles', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Cohort', 'description': 'People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}, {'id': 'OG001', 'title': 'Older Cohort', 'description': 'People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}], 'classes': [{'title': 'Start of cycle', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': '25% through cycle', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': '50% through cycle', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': '75% through cycle', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'End of cycle', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'measured daily over the 3 transfusion cycles', 'description': 'Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.', 'unitOfMeasure': 'percentage of participant-cycles', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant-cycles', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Report of Pain by Length of the Transfusion Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'units': 'Participant-cycles', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '<= 14 Days', 'description': 'Subjects with transfusion cycles of 14 days or less'}, {'id': 'OG001', 'title': '15 - 21 Days', 'description': 'Subjects with transfusion cycles between 15 and 21 days'}, {'id': 'OG002', 'title': '22 - 28 Days', 'description': 'Subjects with transfusion cycles between 22 and 28 days'}, {'id': 'OG003', 'title': '> 28 Days', 'description': 'Subjects with transfusion cycles greater than 28 days'}], 'classes': [{'title': 'Start of cycle', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': '25% through cycle', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '50% through cycle', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '75% through cycle', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'End of cycle', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'measured daily over the 3 transfusion cycles', 'description': 'Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.', 'unitOfMeasure': 'percentage of participant-cycles', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Participant-cycles', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Younger Cohort', 'description': 'People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}, {'id': 'FG001', 'title': 'Older Cohort', 'description': 'People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Both cohorts combined'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2009-03-30', 'resultsFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-12', 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report of Pain by Age Group', 'timeFrame': 'measured daily over the 3 transfusion cycles', 'description': 'Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.'}], 'secondaryOutcomes': [{'measure': 'Report of Pain by Length of the Transfusion Cycle', 'timeFrame': 'measured daily over the 3 transfusion cycles', 'description': 'Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transfusion-Dependant Thalassemia', 'Pain', 'Mild Pain'], 'conditions': ['Thalassemia']}, 'descriptionModule': {'briefSummary': 'Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Regular blood transfusions, which refresh the healthy red blood cell supply, are one treatment for thalassemia. People with thalassemia often experience pain, but the exact source of pain remains unknown. This study will examine how pain varies during the blood transfusion cycle in people with thalassemia who are treated with regular blood transfusions.', 'detailedDescription': "Thalassemia is an inherited blood disorder in which the body makes an abnormal form of hemoglobin-the protein in red blood cells that carries oxygen. People with thalassemia often experience fatigue, shortness of breath, and pain. There have been no previous research studies that have fully examined pain levels in people with thalassemia, and as a result, the sources of pain remain unknown. This study is a substudy of the Assessment of Pain study, which is a Thalassemia Clinical Research Network (TCRN) study that is examining the prevalence and severity of pain in people with transfusion-dependent thalassemia and non-transfusion-dependant thalassemia. This study will enroll a subset of participants from the Assessment of Pain study who have transfusion-dependant thalassemia. The purpose of this study is to examine whether pain varies during the blood transfusion cycle and whether the length of the transfusion cycle affects pain levels in people with transfusion-dependent thalassemia.\n\nParticipants will complete daily questionnaires through an automated telephone system to assess pain levels during three blood transfusion cycles. Each transfusion cycle will last between 2 to 4 weeks, depending on the individual needs of the participant, and the cycles will be separated by at least 3 months but no more than 4 months. Prior to each transfusion cycle, study researchers will review participants' medical records for certain blood level measurements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with transfusion-dependent thalassemia who receive care at sites funded by the Thalassemia Clinical Research Network and their satellites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating in the Thalassemia Clinical Research Network Assessment of Pain study\n* Has a transfusion dependence of at least eight transfusions per year\n* Diagnosis of beta thalassemia or E-beta-thalassemia\n* Experiences at least "mild" pain in the 1 month before study entry, as measured by the response to the Brief Pain Inventory (BPI) question #6 from the Assessment of Pain study\n\nExclusion Criteria:\n\n* Unwillingness or inability to complete the Brief Pain Inventory Short Form (BPI-SF) on a daily basis'}, 'identificationModule': {'nctId': 'NCT00872833', 'briefTitle': 'Assessment of Pain in People With Thalassemia Who Are Treated With Regular Blood Transfusions', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Assessment of Pain in Transfusion Dependent Patients With Thalassemia During Transfusion Cycles', 'orgStudyIdInfo': {'id': '640'}, 'secondaryIdInfos': [{'id': 'U01HL065238', 'link': 'https://reporter.nih.gov/quickSearch/U01HL065238', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'age 18-29', 'description': 'People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}, {'label': 'age 30+', 'description': 'People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University - School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital - Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Dru Foote, NP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Research Institute Oakland"}, {'name': 'Jeanne Boudreaux, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Healthcare of Atlanta"}, {'name': 'Thomas Coates, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital Los Angeles"}, {'name': 'Elliott Vichinsky, MD', 'role': 'STUDY_CHAIR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}, {'name': 'Michael Jeng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stanford University'}, {'name': 'Janet Kwiatkowski, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Nancy Olivieri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Health Network - Toronto General Hospital'}, {'name': 'Patricia J. Giardina, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell'}, {'name': 'Brigitta Mueller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Alexis A. Thompson, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}