Breast CancerFIONANCT04262518
Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients
A study testing Outcomes4Me Mobile App in people with Breast Cancer and Invasive Breast Cancer, run by Outcomes4Me at 1 site in United States.
Trial summary
This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Outcomes4Me Mobile App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Maya Said, Sci.D contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Steven Isakoff, MD
About this study
This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.
Read the detailed description
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.
- Conditions
- Breast Cancer, Invasive Breast Cancer, Metastatic Breast Cancer, Breast Carcinoma, Metastatic Breast Carcinoma
- Being tested
- Outcomes4Me Mobile App
- Keywords
- Invasive Breast Cancer, Metastatic Breast Cancer, NCCN Guidelines, Patient Navigation, Treatment Options, Clinical Trial Options, Symptom Management
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcomes4Me Mobile AppDevice
A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Outcomes4Me App Users | Other | This cohort will download and use the Outcomes4Me mobile app for breast cancer. Receives: Device: Outcomes4Me Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
Measure Net-Promoter Score (NPS) of app usage
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jun 2020
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Outcomes4Me
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Maya Said, Sci.D, Study chair, Outcomes4Me
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262518
- Sponsor's protocol ID
- O4M-B001
- Acronym
- FIONA
- Status last verified
- Jun 2020
- First submitted
- 30 Jan 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37103597
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04262518
- Acronym / sponsor ID
- FIONA / O4M-B001
- Conditions
- Breast Cancer, Invasive Breast Cancer, Metastatic Breast Cancer, Breast Carcinoma, Metastatic Breast Carcinoma
- Keywords
- Invasive Breast Cancer, Metastatic Breast Cancer, NCCN Guidelines, Patient Navigation, Treatment Options, Clinical Trial Options, Symptom Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Outcomes4MeIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outcomes4Me App Users | Other | Device: Outcomes4Me Mobile AppThis cohort will download and use the Outcomes4Me mobile app for breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outcomes4Me Mobile AppA mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer | Device | Outcomes4Me App Users |
Primary outcome
Measure # of times a patient logs into the Outcomes4Me app over a 12 week period
Time frame: 12 Weeks
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.
2 secondary outcomes
Measure System-Usability Score (SUS) of app usage
Time frame: 12 weeks
Measure Net-Promoter Score (NPS) of app usage
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 37103597Isakoff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Said, Sci.D contact
Maya Said, Sci.D study chair
Outcomes4Me
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outcomes4Me Mobile App in people with Breast Cancer and Invasive Breast Cancer, run by Outcomes4Me at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda Stroiney (860-916-4075, amanda@outcomes4me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure # of times a patient logs into the Outcomes4Me app over a 12 week period (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.