Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06571058
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2024-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007316', 'term': 'Insemination, Artificial, Heterologous'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karen.Meade@osumc.edu', 'phone': '614-366-5060', 'title': 'Karen Meade', 'organization': 'The Ohio State University Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during intervention for each participant, a time period that lasted up to 20 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.\n\nAssistance: Assist patient with walking approximately 90 feet\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nRemove: Remove the device and return urinary drainage bag to the standard position', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Wear the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nWalking: Walk approximately 90 feet', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.\n\nAssistance: Assist patient with walking approximately 90 feet\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nRemove: Remove the device and return urinary drainage bag to the standard position'}, {'id': 'OG001', 'title': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Wear the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nWalking: Walk approximately 90 feet'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 17 minutes', 'description': 'The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for "completely disagree") to 5 (for "completely agree"). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a "4," the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Acceptability of device was only measured for patient arm.'}, {'type': 'PRIMARY', 'title': 'Usability of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.\n\nAssistance: Assist patient with walking approximately 90 feet\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nRemove: Remove the device and return urinary drainage bag to the standard position'}, {'id': 'OG001', 'title': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Wear the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nWalking: Walk approximately 90 feet'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '95.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 minutes', 'description': 'Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Usability of device was only measured for the clinician arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.\n\nAssistance: Assist patient with walking approximately 90 feet\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nRemove: Remove the device and return urinary drainage bag to the standard position'}, {'id': 'FG001', 'title': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Wear the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nWalking: Walk approximately 90 feet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.\n\nAssistance: Assist patient with walking approximately 90 feet\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nRemove: Remove the device and return urinary drainage bag to the standard position'}, {'id': 'BG001', 'title': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nEducational Intervention: Receive a short instructional session\n\nMedical Device Usage and Evaluation: Wear the B3 Buddy device\n\nQuestionnaire Administration: Ancillary studies\n\nWalking: Walk approximately 90 feet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', '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': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex demographics were not collected for the Clinicians arm'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-12', 'size': 410227, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-24T13:52', 'hasProtocol': True}, {'date': '2023-06-12', 'size': 48850, 'label': 'Informed Consent Form: Clinician Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-14T15:45', 'hasProtocol': False}, {'date': '2023-06-12', 'size': 59792, 'label': 'Informed Consent Form: Patient Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-14T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-06-27', 'resultsFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-28', 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Device', 'timeFrame': 'Up to 17 minutes', 'description': 'The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for "completely disagree") to 5 (for "completely agree"). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a "4," the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses.'}, {'measure': 'Usability of Device', 'timeFrame': 'Up to 20 minutes', 'description': 'Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary System Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To evaluate the acceptability of the B3 Buddy, from the patient's perspective.\n\nII. To evaluate the usability of the B3 Buddy, from the clinician's perspective.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nPATIENTS: Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.\n\nCLINICIANS: Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENT PARTICIPANT: Must be English-speaking\n* PATIENT PARTICIPANT: Able to comprehend and agree to consent\n* PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey\n* PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device\n* PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag\n* PATIENT PARTICIPANT: Have no restrictions in ambulation\n* CLINICIAN PARTICIPANT: Must be English-speaking\n* CLINICIAN PARTICIPANT: Able to comprehend and agree to consent\n* CLINICIAN PARTICIPANT: Able to read and complete the System Usability Scale (SUS) survey\n* CLINICIAN PARTICIPANT: Be willing to participate using the B3 Buddy device\n* CLINICIAN PARTICIPANT: Have a professional role in assisting patients in ambulation in normal workday activities\n\nExclusion Criteria:\n\n* Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device'}, 'identificationModule': {'nctId': 'NCT06571058', 'briefTitle': 'B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences', 'orgStudyIdInfo': {'id': 'OSU-22357'}, 'secondaryIdInfos': [{'id': 'NCI-2024-04927', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinicians (B3 Buddy)', 'description': 'Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.', 'interventionNames': ['Other: Assistance', 'Other: Educational Intervention', 'Other: Medical Device Usage and Evaluation', 'Other: Questionnaire Administration', 'Procedure: Remove']}, {'type': 'EXPERIMENTAL', 'label': 'Patients (B3 Buddy)', 'description': 'Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.', 'interventionNames': ['Other: Educational Intervention', 'Device: Medical Device Usage and Evaluation', 'Other: Questionnaire Administration', 'Other: Walking']}], 'interventions': [{'name': 'Assistance', 'type': 'OTHER', 'otherNames': ['Aid', 'Assist', 'Help'], 'description': 'Assist patient with walking approximately 90 feet', 'armGroupLabels': ['Clinicians (B3 Buddy)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive a short instructional session', 'armGroupLabels': ['Clinicians (B3 Buddy)', 'Patients (B3 Buddy)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'DEVICE', 'description': 'Wear the B3 Buddy device', 'armGroupLabels': ['Patients (B3 Buddy)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Secure the urinary drainage bag to the patient using the B3 Buddy device', 'armGroupLabels': ['Clinicians (B3 Buddy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Clinicians (B3 Buddy)', 'Patients (B3 Buddy)']}, {'name': 'Remove', 'type': 'PROCEDURE', 'otherNames': ['Removal'], 'description': 'Remove the device and return urinary drainage bag to the standard position', 'armGroupLabels': ['Clinicians (B3 Buddy)']}, {'name': 'Walking', 'type': 'OTHER', 'otherNames': ['Ambulation', 'By Foot', 'On Foot', 'Walk'], 'description': 'Walk approximately 90 feet', 'armGroupLabels': ['Patients (B3 Buddy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Karen Meade, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karen Meade', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}