Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-11 @ 3:41 AM
Study NCT ID:
NCT03707860
Status:
WITHDRAWN
Last Update Posted:
2022-05-27
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Oncology Mobile Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "the program couldn't be implemented", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2018-10-12', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of symptoms improved with early intervention.', 'timeFrame': 'only during RT (7WEEKS)', 'description': 'using CTCAE v.5'}], 'secondaryOutcomes': [{'measure': 'compliance on the mobile.', 'timeFrame': 'Only during RT (7WEEKS)', 'description': 'number of reports.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer', 'Radiation Toxicity']}, 'descriptionModule': {'briefSummary': "To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule.\n\nIn addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks.\n\nFurthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to our radiation oncology clinic with head and neck cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone\n\nExclusion Criteria:\n\nPoor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.'}, 'identificationModule': {'nctId': 'NCT03707860', 'acronym': 'γ-App', 'briefTitle': 'Radiation Oncology Mobile Application', 'organization': {'class': 'OTHER', 'fullName': 'King Hussein Cancer Center'}, 'officialTitle': 'Radiation Oncology Mobile Application: Symptoms Reporting System and Quality Assurance Tool', 'orgStudyIdInfo': {'id': '18 KHCC 86'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'head and neck radiotherapy patients', 'description': '(Single arm); Patients receiving radiotherapy for head and neck cancers can report their symptoms through the mobile app.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11941', 'city': 'Amman', 'country': 'Jordan', 'facility': 'King Hussein Cancer Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hussein Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Radiation Oncology', 'investigatorFullName': 'Ramiz Abu-Hijlih', 'investigatorAffiliation': 'King Hussein Cancer Center'}}}}