Clinical trial · Interventional
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients
NCT04262518CI-TRIAL-00045551FIONAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Outcomes4Me Mobile App | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- 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.
Secondary outcomes (2)
- measure
- Measure System-Usability Score (SUS) of app usage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older, with histologically or cytologically confirmed invasive breast cancer stage I-IV * 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 * Must be able to understand, read, and write in English and be able to sign informed consent * Must have an Apple or Android smart phone that they are able to use and download the Outcomes4Me app on * Must have the ability to access the internet at least once per week via their smart phone (having a computer is not required) Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDIsakoff 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. PMID 37103597