Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT05478135
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation
Sponsor:
Organization:
Raw JSON
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Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.", 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'System Usability Scale (SUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 mins', 'description': "The System Usability Scale (SUS) a reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly disagree to Strongly agree. The participant's scores for each question added together and multiplied by 2.5 to convert the original scores of 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.", 'unitOfMeasure': 'score on SUS', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant-reported Efficiency When Preparing for Patient Consultations, Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 mins', 'description': 'Count of participants self-reporting that they were "a lot more efficient" or "somewhat more efficient" when using navify Oncology Hub to review patient information.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'NASA Task Load Index (NASA-TLX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 mins', 'description': 'Number of participants who required "low" or "very low" levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant-reported Efficacy of Using Navify Oncology Hub to Facilitate Patient Discussions and Collaborate Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 mins', 'description': 'Number of participants self-reporting who felt nOH would be "significantly better" or "somewhat better" than their existing solution at facilitating patient discussion and coordinating care.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant-reported Fidelity of Synthetic Patient Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. 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In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '27 US oncologists who are actively practicing and treat breast cancer were recruited during August and September 2022. Participants were affiliated with a healthcare institution where they are an active member of a tumor board and spend at least 50% of their time in clinical practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Navify Oncology Hub', 'description': "We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.\n\nNAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Board certification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Board-certified US oncologists', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-06', 'size': 149377, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-16T12:00', 'hasProtocol': True}, {'date': '2022-08-11', 'size': 56035, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-29T05:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2022-07-22', 'resultsFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-06', 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (SUS)', 'timeFrame': '90 mins', 'description': "The System Usability Scale (SUS) a reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly disagree to Strongly agree. The participant's scores for each question added together and multiplied by 2.5 to convert the original scores of 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average."}, {'measure': 'Participant-reported Efficiency When Preparing for Patient Consultations, Likert Scale', 'timeFrame': '90 mins', 'description': 'Count of participants self-reporting that they were "a lot more efficient" or "somewhat more efficient" when using navify Oncology Hub to review patient information.'}, {'measure': 'NASA Task Load Index (NASA-TLX)', 'timeFrame': '90 mins', 'description': 'Number of participants who required "low" or "very low" levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub.'}, {'measure': 'Participant-reported Efficacy of Using Navify Oncology Hub to Facilitate Patient Discussions and Collaborate Care', 'timeFrame': '90 mins', 'description': 'Number of participants self-reporting who felt nOH would be "significantly better" or "somewhat better" than their existing solution at facilitating patient discussion and coordinating care.'}, {'measure': 'Participant-reported Fidelity of Synthetic Patient Cases', 'timeFrame': '90 mins', 'description': "Number of participants self-reporting that the synthetic patient cases were either 'very similar' or 'somewhat similar' to cases seen in routine clinical practice"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Health', 'Health tech', 'Clinical simulation', 'Healthcare technology'], 'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': "This work seeks to understand current clinical workflow practice and validate use cases for NAVIFY Oncology Hub.\n\nThe main purpose of NAVIFY Oncology Hub is to enhance clinical and operational effectiveness, from diagnostic workup to treatment planning and management. This might free up providers' time and capacity to provide better and more personalized care to patients.\n\nThis research protocol builds on previous work that validated clinical simulation methods as a means for clinicians to generate useful insights during the testing and development of digital health tools (Gardner et al. 2020).\n\nAccordingly, this study aims to test the ability of NAVIFY Oncology Hub to increase the work efficiency of oncologists and reduce the cognitive burden/mental fatigue associated with patient care and decision-making.\n\nThe insights generated will be used to guide the development of NAVIFY Oncology Hub and optimise user experience, as well as provide a better understanding of the opportunities for it to have maximal impact in the decision-making process.", 'detailedDescription': "NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.\n\nClinical workflow is critical for the efficient and safe delivery of patient care. In most healthcare settings, clinical workflow is highly complex, and reflects the multidisciplinary collaboration and communication required of most clinical tasks. Studies have demonstrated a positive association between leveraging health information technology workflow tools for care coordination and patient engagement, and improved process quality metrics in preventive screening, diabetes control, as well as maternal and child health (Kruse \\& Bean 2018; Kranz et al. 2018). Embedded decision support tools have also been proven to improve the performance of risk assessments conducted by providers, as well as enhance patient safety and decrease mortality (Chaudhry et al. 2006; Wells et al. 2008; Jones et al. 2014; Campanella et al. 2015).\n\nA set of 10 synthetic breast cancer patient cases will be developed by Prova Health. Cases will include history and examination findings, pathology reports, radiology reports and images (USS, mammogram, CT as applicable) and reports on tumor characteristics. The case details will be representative of a long term patient journey, inclusive of treatment lines such as adjuvant and neoadjuvant therapies. Cases will be selected to span the range of potential case scenarios seen in typical practice. Specifically, cases will be selected to include common invasive breast cancers (eg. IDC, ILC), as well as less common invasive breast cancers (eg. inflammatory). Cases will also represent a range of cancers with different molecular subtypes, such as whether the patient is HER2 positive or negative, hormone receptor (HR) positive or negative or triple negative. Finally, cases will also reflect the presentation of patients at various stages (eg. primary diagnosis, locally and regional advanced breast cancer, recurrent breast cancer, or metastatic advanced breast cancer).\n\nEach participant will participate in a 90-minute remote (e.g., online) simulation session. During scheduling, participants will be given a link to use to join the session. This link will take them to a video conference call hosted through Google Meet. At the session, the moderator will facilitate the session and take notes.\n\nParticipants will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. This task will involve searching for, identifying, reviewing and synthesizing relevant clinical information (demographic information, pathology reports, clinical course, etc.) that supports decision-making. As such, this task is meant to simulate the same activities they would perform in their typical practice before inviting a patient into the clinic room for a consultation, and will permit this study to examine the usage of NAVIFY Oncology Hub on those activities.\n\nUltimately, the aim of the study is to investigate how NAVIFY Oncology Hub improves efficiency and reduces cognitive burden associated with reviewing and synthesizing patient information, and having participants engage with the platform requires them to go through those tasks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Board-certified, US-based oncologist\n* Minimum 50% spent in clinical practice\n* Active member of a tumor board\n\nExclusion criteria:\n\n* Experience using NAVIFY Oncology Hub\n* Inability to speak English'}, 'identificationModule': {'nctId': 'NCT05478135', 'briefTitle': 'A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Prova Health Limited'}, 'officialTitle': 'A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation', 'orgStudyIdInfo': {'id': 'HLR-NOH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAVIFY Oncology Hub', 'description': 'We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.', 'interventionNames': ['Device: NAVIFY Oncology Hub']}], 'interventions': [{'name': 'NAVIFY Oncology Hub', 'type': 'DEVICE', 'description': "NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.", 'armGroupLabels': ['NAVIFY Oncology Hub']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE13XF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Prova Health Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Saira J Ghafur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prova Health Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study will not share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prova Health Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}