Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT01084694
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013315', 'term': 'Stress, Psychological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dawn.speckhart@northside.com', 'phone': '404-255-1930', 'title': 'Dr. Dawn Speckhart, PhD', 'organization': 'Northside Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Undergoing Autologous Transplant', 'description': 'Patients undergoing autologous transplant', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients Undergoing Allogeneic Transplant', 'description': 'Patients undergoing allogeneic transplant', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Caregivers for Patients Undergoing Autologous Transplant', 'description': 'Caregivers for patients undergoing autologous transplant. Only emotional distress was monitored for the caregivers.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Caregivers for Patients Undergoing Allogeneic Transplants', 'description': 'Caregivers for patients undergoing allogeneic transplant. Only emotional distress was monitored for the caregivers', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brief Symptom Inventory and Burden Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Transplant Recipients', 'description': 'patients receiving autologous transplant'}, {'id': 'OG001', 'title': 'Allogeneic Transplant Recipients', 'description': 'patients receiving allogeneic transplants'}], 'classes': [{'title': 'Baseline BSI', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}]}]}, {'title': 'Day 30 BSI', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}]}]}, {'title': '1 year BSI', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '39'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '39'}]}]}, {'title': 'Baseline Burden', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '39'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '39'}]}]}, {'title': 'Day 30 Burden', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '35'}]}]}, {'title': '1 year Burden', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30 & 1 year', 'description': 'Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88.\n\nTime frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '74 caregivers met criteria for analysis'}, {'type': 'SECONDARY', 'title': 'Patient Distress, Fatigue & Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Transplant Recipients', 'description': 'patients receiving an autologous transplant'}, {'id': 'OG001', 'title': 'Allogeneic Transplant Recipients', 'description': 'Patients receiving an allogeneic transplant'}], 'classes': [{'title': 'Baseline BSI', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '31'}]}]}, {'title': 'Baseline BFI', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '59'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '59'}]}]}, {'title': 'Baseline BPI', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '66'}]}]}, {'title': 'Day 30 BSI', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '31'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}]}]}, {'title': 'Day 30 BFI', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '67'}]}]}, {'title': 'Day 30 BPI', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '71'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '72'}]}]}, {'title': '1 year BSI', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '33'}]}]}, {'title': '1 year BFI', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '63'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '64'}]}]}, {'title': '1 year BPI', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30 & 1 year', 'description': 'BSI scale 0-72 with the higher score representing higher distress Brief Fatigue inventory 0-90 with the higher score representing higher fatigue Brief Pain inventory 0-120 with the higher score representing higher pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was assessed in patients.'}, {'type': 'SECONDARY', 'title': 'Overall Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Transplant Recipients', 'description': 'Patients receiving autologous transplant'}, {'id': 'OG001', 'title': 'Allogeneic Transplant Recipients', 'description': 'Patients receiving allogeneic transplants'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-transplant to 1 year post-transplant', 'description': 'Number of patients who are alive at 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Common Characteristics of Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers for Autologous Transplant Recipients', 'description': 'Caregivers of patients who had autologous transplants'}, {'id': 'OG001', 'title': 'Caregivers for Allogeneic Transplant Recipients', 'description': 'Caregivers for patients who were receiving an allogeneic transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': '12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress', 'unitOfMeasure': 'common characteristics', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers were analyzed'}, {'type': 'SECONDARY', 'title': 'Length of Patient Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Transplant Recipients', 'description': 'patients receiving an autologous transplant'}, {'id': 'OG001', 'title': 'Allogeneic Transplant Recipients', 'description': 'Patients receiving an allogeneic transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '10.72', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '76'}, {'value': '29.34', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '119'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pretransplant to 1 year post-transplant', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Undergoing Autologous Transplant', 'description': '50% of patients enrolled in this study will be undergoing autologous transplant with one primary caregiver.'}, {'id': 'FG001', 'title': 'Patients Undergoing Allogeneic Transplant', 'description': '50% of patients enrolled in this study will be undergoing allogeneic transplant with one primary caregiver.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'eligibility not maintained', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Patients will be selected from our Program and will be undergoing evaluation for stem cell transplant.', 'preAssignmentDetails': 'Patients and caregivers were enrolled as dyads. Data was collected from both patients and caregivers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Autologous Transplant', 'description': '50 pairs of autologous patients and their caregivers were enrolled'}, {'id': 'BG001', 'title': 'Allogeneic Transplant', 'description': '50 pairs of allogeneic patients and their caregivers were enrolled'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of enrollment for patients', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of enrollment for caregivers', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-16', 'size': 321726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-07T14:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2010-03-09', 'resultsFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-13', 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Symptom Inventory and Burden Interview', 'timeFrame': 'Baseline, Day 30 & 1 year', 'description': 'Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88.\n\nTime frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).'}], 'secondaryOutcomes': [{'measure': 'Patient Distress, Fatigue & Pain Scores', 'timeFrame': 'Baseline, Day 30 & 1 year', 'description': 'BSI scale 0-72 with the higher score representing higher distress Brief Fatigue inventory 0-90 with the higher score representing higher fatigue Brief Pain inventory 0-120 with the higher score representing higher pain'}, {'measure': 'Overall Patient Survival', 'timeFrame': 'Pre-transplant to 1 year post-transplant', 'description': 'Number of patients who are alive at 1 year'}, {'measure': 'Common Characteristics of Caregivers', 'timeFrame': 'Baseline', 'description': '12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress'}, {'measure': 'Length of Patient Hospitalization', 'timeFrame': 'pretransplant to 1 year post-transplant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HSCT', 'Caregiver', 'Caregiver Burden', 'Allogeneic Transplant', 'Autologous Transplant', 'Hematopoietic Stem Cell Transplantation'], 'conditions': ['Depression', 'Anxiety', 'Fatigue', 'Distress']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. It will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient:\n\n* Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital\n* Patients must have a single primary caregiver\n* Patients must be willing to comply with all assessments as outlined in the protocol\n* Patients must be willing to sign informed consent\n\nCaregiver:\n\n* Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital\n* Caregiver must be willing to comply will all assessments as outlined in the protocol\n* Caregiver must be willing to sign consent'}, 'identificationModule': {'nctId': 'NCT01084694', 'briefTitle': 'Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Northside Hospital, Inc.'}, 'officialTitle': 'The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress', 'orgStudyIdInfo': {'id': 'NSH 888'}}, 'contactsLocationsModule': {'locations': [{'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Dawn Speckhart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northside Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northside Hospital, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}