Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02033759
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2014-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Anxiety Associated With Lymphedema Surveillance Method
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D008209', 'term': 'Lymphedema'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah@stolker.com', 'phone': '13145402858', 'title': 'Sarah Stolker, MSPT, CLT-LANA', 'organization': 'Mercy Integrative Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our study used the Beck Anxiety Inventory, with its greater focus on physical symptoms of anxiety, and this approach may not have been as sensitive for identifying emotional distress when compared with other psychological tools.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}, {'id': 'OG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '31'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}, {'id': 'OG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}, {'id': 'OG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}, {'id': 'FG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Traditional Circumferential Measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire\n\nAnxiety Questionnaire: 21 item questionnaire\n\nTraditional Circumferential Measurements\n\nTraditional screening involved circumferential measurements using a tape measure, every 4cm from the wrist to the axilla, after which a standardized computer algorithm calculated limb volume in milliliters. Significant changes were defined as \\>3% volume increase when compared with the preoperative baseline limb measurements, without other clear explanation (commonly accepted unilateral volume change according to the International Society of Lymphology).'}, {'id': 'BG001', 'title': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire\n\nBio-Impedance Testing: Participants in the BIA Arm will also undergo bio-impedance testing with this device.\n\nAnxiety Questionnaire: 21 item questionnaire\n\nBIS measurements involved the placement of adhesive electrodes on each wrist and the right ankle, followed by connection of the electrodes to the BIS machine (L-Dex U-400, ImpediMed Ltd). The L-Dex uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs.6, 9-13 This tool compares readings to normative data to determine if significant asymmetry exists, or if the current reading is \\>2 standard deviations from the baseline reading for that individual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Patient was excluded due to exclusion criteria'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '40'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '42'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '42'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMI (kg/m^2) Average', 'dispersionType': 'FULL_RANGE'}, {'title': 'Anxiety', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '12.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '9.6', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2014-01-07', 'resultsFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-14', 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': '6 weeks post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.'}, {'measure': 'Anxiety', 'timeFrame': '3 months post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.'}, {'measure': 'Anxiety', 'timeFrame': '6 months post-op', 'description': 'The Beck Anxiety Score is a measurement on a scale from 0 to 63 obtained by using the Beck Anxiety Inventory tool to assess symptoms of anxiety. A higher score correlates to increased anxiety whereas a lower score expresses a lower amount of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphedema'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'We propose to study the impact of BIA screening on anxiety and primary prevention strategies for lymphedema development among patients with recent surgery for breast cancer. Currently, professional societies recommend scheduled follow-up visits to screen for lymphedema after recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk reduction strategies, measurement of the affected limb with a tape measure, and physical inspection for physical changes consistent with lymphedema. In the proposed study, patients will be randomly assigned to the addition of BIA screening vs. usual care. At each screening visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior studies of patients with breast cancer (8,9). This questionnaire will be administered at each follow-up lymphedema screening visit, and the baseline will be administered at the preoperative visit. For patients randomly assigned to BIA screening, this involves the placement of adhesive electrodes on the each wrist and an ankle, followed by connection of the electrodes to the BIA machine, which then uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors and anxiety levels between those patients with vs. without BIA screening.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women recently diagnosed with breast cancer Age 18 and older\n\nExclusion Criteria:\n\n\\- Those women with a pacemaker'}, 'identificationModule': {'nctId': 'NCT02033759', 'briefTitle': 'Patient Anxiety Associated With Lymphedema Surveillance Method', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'A Study of Patient Anxiety Associated With Lymphedema Surveillance: Comparing Volumetric Analysis and Bio-Impedance Analysis', 'orgStudyIdInfo': {'id': 'Anxiety & Lymphedema'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional circumferential measurements', 'description': 'Traditional screening with volumetric analysis Patient Anxiety Questionnaire', 'interventionNames': ['Other: Anxiety Questionnaire', 'Other: Traditional Circumferential Measurements']}, {'type': 'EXPERIMENTAL', 'label': 'Bio-Impedance Testing', 'description': 'Traditional Screening with Volumetric Analysis and Bio-Impedance Analysis Patient Anxiety Questionnaire', 'interventionNames': ['Device: Bio-Impedance Testing', 'Other: Anxiety Questionnaire', 'Other: Traditional Circumferential Measurements']}], 'interventions': [{'name': 'Bio-Impedance Testing', 'type': 'DEVICE', 'otherNames': ['LTU-400 by Impedimed'], 'description': 'Participants in the BIA Arm will also undergo bio-impedance testing with this device.', 'armGroupLabels': ['Bio-Impedance Testing']}, {'name': 'Anxiety Questionnaire', 'type': 'OTHER', 'otherNames': ['Beck Anxiety Inventory will be administered.'], 'description': '21 item questionnaire', 'armGroupLabels': ['Bio-Impedance Testing', 'Traditional circumferential measurements']}, {'name': 'Traditional Circumferential Measurements', 'type': 'OTHER', 'armGroupLabels': ['Bio-Impedance Testing', 'Traditional circumferential measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Clarkson/Clayton', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'POSTER PRESENTATION AT ACRM CONFERENCE CHICAGO NOV 2016'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Sarah Stolker', 'investigatorAffiliation': 'Mercy Integrative Medicine'}}}}