Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT06927050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Communication: Digital Tool to Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of "Satisfied" Patients', 'timeFrame': 'Day 0', 'description': 'Patients will take a 9-item survey assessing satisfaction with the intervention. Each item is rated as "Yes" or "No." The total score is the sum of "Yes" responses; patients with 6 or more "Yes" answers out of 9 questions are defined as "Satisfied" patients.'}], 'secondaryOutcomes': [{'measure': 'Percentage of "Satisfied" Caregivers', 'timeFrame': 'Day 0', 'description': 'Caregivers of patients (if applicable) will take a 10-item survey assessing satisfaction with the intervention. Each item is rated as "Yes" or "No." The total score is the sum of "Yes" responses; caregivers with 7 or more "Yes" answers out of 10 questions will be defined as "Satisfied" caregivers.'}, {'measure': 'Percentage of "Satisfied" Providers', 'timeFrame': 'Day 0', 'description': 'For each patient encountered, providers will take a 5-item survey assessing satisfaction with the intervention. Each item is rated as "Yes" or "No." The total score is the sum of "Yes" responses; a provider with 3 or more "Yes" answers out of 5 questions for a patient will be defined as a "Satisfied" provider for this patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This is a study in patients with newly diagnosed cancer to prospectively evaluate the feasibility of integration of a visual communication tool for patients/caregivers/providers by determining whether such a tool can increase overall satisfaction with the patient experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Patients seen in consultation from 12/1/2024-6/1/2025\n* Patients aged 18 years to 100 years old\n* Patients with a malignancy of breast or head and neck\n* English speaking patients\n* Patients being treated with definitive intent\n* Patients treated at NYU Langone Health for their malignancy\n* Willing and able to provide consent\n\nCaregivers:\n\n* Any adult caregiver(s) (aged 18 years to 100 years old) to a patient who fulfills the inclusion and exclusion criteria above.\n* Willing and able to provide consent\n\nProviders:\n\n* Doctors and nurse practitioners in medical oncology and radiation oncology, and in the ear nose throat (ENT) department.\n* Willing and able to provide consent\n* aged 18 years to 100 years old\n\nExclusion Criteria:\n\nPatients:\n\n* Patients with any other site of disease other than listed above\n* Non-English-speaking patients, as the tool is currently available in English only. Translation into additional languages such as Spanish and Russian is currently in process.\n* Patient unable to complete the survey portion of the study independently\n\nCaregivers:\n\n• Unable to complete the survey portion of the study independently'}, 'identificationModule': {'nctId': 'NCT06927050', 'briefTitle': 'Visual Communication: Digital Tool to Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Visual Communication: Can a Digital Tool Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers?', 'orgStudyIdInfo': {'id': '24-01870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients (and caregivers) recently diagnosed with cancer', 'description': 'Enrolled patients will receive a tool during the patient consultation encounter to explain their disease location and stage, role of radiation, logistics of radiation treatment delivery and sequencing of treatment. Following the encounter, a survey will be provided.\n\nIf patients are accompanied by a caregiver(s), they will also receive a survey.', 'interventionNames': ['Behavioral: Visual Communication Tool']}], 'interventions': [{'name': 'Visual Communication Tool', 'type': 'BEHAVIORAL', 'otherNames': ['MyCareGorithm'], 'description': 'MyCareGorithm will be used during the patient consultation encounter to explain their disease location and stage, role of radiation, logistics of radiation treatment delivery and sequencing of treatment. MyCareGorithm is an online educational tool that will be displayed to the patient via iPad or Microsoft tablet.', 'armGroupLabels': ['Patients (and caregivers) recently diagnosed with cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jason Domogauer, MD, PhD', 'role': 'CONTACT', 'email': 'Jason.Domogauer@nyulangone.org', 'phone': '(212) 501-5003'}, {'name': 'Julie Xiao', 'role': 'CONTACT', 'email': 'julie.xiao@nyulangone.org', 'phone': '(646) 501-2918'}], 'overallOfficials': [{'name': 'Jason Domogauer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jason.Domogauer@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jason.Domogauer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}