Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 5:44 PM
Study NCT ID:
NCT05344950
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connecting Audio and Radio Sensing Systems to Improve Care at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011845', 'term': 'Radio'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with the AURA system', 'timeFrame': '1-month followup survey', 'description': 'Satisfaction with the AURA system will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.'}, {'measure': 'Perceived ease of use of the PRISMS program', 'timeFrame': '1-month followup survey', 'description': 'Perceived ease of use of the AURA system will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ostomy (colostomy, urostomy, and ileostomy)', 'symptom', 'self-management', 'caregiving', 'family research', 'telehealth', 'self-efficacy', 'quality of life', 'post-treatment care transition'], 'conditions': ['Colorectal Cancer', 'Bladder Cancer', 'Ovarian Cancer', 'Cervical Cancer', 'Uterine Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'Clinical trials at UNC Lineberger'}]}, 'descriptionModule': {'briefSummary': "This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information on patient's daily activities and answers to survey questionnaire, and enabling access to this information through a voice assistant device.", 'detailedDescription': "The investigators will assign up to 30 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the AURA or usual care groups (up to 30 patient-caregiver dyads, a total of 60 individuals). AURA is defined as a system that connects audio-based voice assistant devices with radiofrequency (RF) sensing technology to gather relevant patient information automatically, interactively, and with context-awareness and to store a patient's health records that otherwise had to be measured and entered manually into an electronic system. Additionally, the system enables user's access to this information through a voice assistant device. The users of this system will be the entire care team, consisting of the patient and their family members as well as the caregivers and healthcare providers at remote sites. If results indicate that the pilot trial is feasible, the investigators will design and conduct a definitive trial to examine the efficacy of AURA, a potentially scalable intervention that can be disseminated through oncology clinics nationwide to enhance post-treatment care for cancer patients with ostomies who transition from hospital professional care to self-management at home and their caregivers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects receive treatment and their caregivers partners.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPhase I: The investigators will only be recruiting patients for this phase\n\nPatients must:\n\n* have been surgically treated for colorectal or bladder cancer with curative intent;\n* have had an ostomy with curative intent for at least 90 days;\n* be able to read and speak English;\n* be 18 years or older;\n\nPhase II: The investigators will be recruiting patients and caregivers as a dyad for this phase\n\n* Patients must:\n\n * have been surgically treated for colorectal or bladder cancer with curative intent;\n * be within one month of hospital discharge of a newly created ostomy with curative intent;\n * be able to read and speak English;\n * be 18 years or older;\n * have a caregiver who is willing to participate in the study;\n* Caregivers must:\n\n * be 18 years or older;\n * be able to read and speak English;\n * be identified as the primary caregiver by the patient;\n * have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).\n\nExclusion Criteria\n\nPatients and their caregivers will be excluded if they:\n\n* are unable to read, speak, or understand English;\n* have more than one type of ostomy;\n* have other cancer diagnosis (excluding non-melanomatous skin cancer); or\n* have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).'}, 'identificationModule': {'nctId': 'NCT05344950', 'acronym': 'AURA', 'briefTitle': 'Connecting Audio and Radio Sensing Systems to Improve Care at Home', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Development and Pilot Testing of AURA', 'orgStudyIdInfo': {'id': 'LCCC2123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AURA', 'description': 'In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.', 'interventionNames': ['Behavioral: Audio + Radio (AURA)']}], 'interventions': [{'name': 'Audio + Radio (AURA)', 'type': 'BEHAVIORAL', 'description': "Participants will receive personalized self-care information based on their symptoms and signs of complications (e.g., fatigue) from interacting with our voice assistant device, connected to a system that integrating the patient-reported outcome and objective data from passive RF sensing to provide continuous monitoring of patients' symptoms and complications after they are discharged home.", 'armGroupLabels': ['AURA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health San Antonio MD Anderson Cancer Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Shahriar Nirjon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. National Science Foundation', 'class': 'FED'}, {'name': 'National Library of Medicine (NLM)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}