Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-09 @ 9:53 PM
Study NCT ID:
NCT04262518
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-13', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure # of times a patient logs into the Outcomes4Me app over a 12 week period', 'timeFrame': '12 Weeks', 'description': 'We will track engagement with the app by tracking the number of times a user logs in to the Outcomes4Me app over a 12 week period. The app will be considered feasible if at least 40% of enrolled patients engage with the Outcomes4Me app at least 3 times during the 12-week study period.'}], 'secondaryOutcomes': [{'measure': 'Measure System-Usability Score (SUS) of app usage', 'timeFrame': '12 weeks', 'description': 'Usability will be assessed using the System Usability Scale (SUS). We wil collect the input of breast cancer patients to the SUS questions, using in-app surveys and will calculate the SUS score. We will assess overall satisfaction with the app by asking users to provide an answer to the question "How likely are you to recommend this product to a friend" on a scale of 0-10.'}, {'measure': 'Measure Net-Promoter Score (NPS) of app usage', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Invasive Breast Cancer', 'Metastatic Breast Cancer', 'NCCN Guidelines', 'Patient Navigation', 'Treatment Options', 'Clinical Trial Options', 'Symptom Management'], 'conditions': ['Breast Cancer', 'Invasive Breast Cancer', 'Metastatic Breast Cancer', 'Breast Carcinoma', 'Metastatic Breast Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37103597', 'type': 'DERIVED', 'citation': "Isakoff SJ, Said MR, Kwak AH, Glieberman E, O'Rourke EA, Stroiney A, Spring LM, Moy B, Bardia A, Horick N, Peppercorn JM. Feasibility of introducing a smartphone navigation application into the care of breast cancer patients (The FIONA Study). Breast Cancer Res Treat. 2023 Jun;199(3):501-509. doi: 10.1007/s10549-023-06918-y. Epub 2023 Apr 27."}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.', 'detailedDescription': "This protocol is a single arm pilot study of a novel breast cancer navigation app that is intended to assist patients with breast cancer understand their diagnosis and treatment options (both as part of standard of care practice and clinical trials) and manage their care, through treatment and symptom tracking. Patients will also be able to share information and get news via the app relevant to their cancer subtype. Results from this intervention will inform future clinical integration efforts, improve patient-centeredness of such an app-based health content and data platform, and inform the design of a larger, randomized study to demonstrate an improvement in patients' outcomes as well as enhanced Real-World Evidence (RWE) data collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older, with histologically or cytologically confirmed invasive breast cancer stage I-IV\n* Must be on, or planning to be on within 4 weeks of registration, active therapy, with the intent to receive some element of active therapy \\> 28 days after registration\n* Must be able to understand, read, and write in English and be able to sign informed consent\n* Must have an Apple or Android smart phone that they are able to use and download the Outcomes4Me app on\n* Must have the ability to access the internet at least once per week via their smart phone (having a computer is not required)\n\nExclusion Criteria:\n\n* Participations seen for consultation opinion only and are not planning to receive some element of active treatment from an MGH medical or radiation oncology provider at MGH (Boston or Waltham sites) during the 12-week study period'}, 'identificationModule': {'nctId': 'NCT04262518', 'acronym': 'FIONA', 'briefTitle': 'Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Outcomes4Me'}, 'officialTitle': 'Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'O4M-B001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Outcomes4Me App Users', 'description': 'This cohort will download and use the Outcomes4Me mobile app for breast cancer.', 'interventionNames': ['Device: Outcomes4Me Mobile App']}], 'interventions': [{'name': 'Outcomes4Me Mobile App', 'type': 'DEVICE', 'description': 'A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer', 'armGroupLabels': ['Outcomes4Me App Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Isakoff, MD', 'role': 'CONTACT'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Amanda Stroiney', 'role': 'CONTACT', 'email': 'amanda@outcomes4me.com', 'phone': '860-916-4075'}, {'name': 'Maya Said, Sci.D', 'role': 'CONTACT', 'phone': '617-794-4963'}], 'overallOfficials': [{'name': 'Maya Said, Sci.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Outcomes4Me'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Outcomes4Me', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}