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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outcomes4Me App Users | Other | This cohort will download and use the Outcomes4Me mobile app for breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outcomes4Me Mobile App | Device | A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure # of times a patient logs into the Outcomes4Me app over a 12 week period | 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure System-Usability Score (SUS) of app usage | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Stroiney | Contact | 860-916-4075 | amanda@outcomes4me.com | |
| Maya Said, Sci.D | Contact | 617-794-4963 |
| Name | Affiliation | Role |
|---|---|---|
| Maya Said, Sci.D | Outcomes4Me | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37103597 | Derived | 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. |
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| 12 weeks |
| Measure Net-Promoter Score (NPS) of app usage | 12 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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