Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

Breast Cancer Clinical Trial

— FIONA  

Official title:

Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application Into the Care Management of Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262518
• Other study ID #: O4M-B001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 2020

Study information

• Verified date: June 2020
• Source: Outcomes4Me
• Contact: Amanda Stroiney
• Phone: 860-916-4075
• Email: amanda[@]outcomes4me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Invasive Breast Cancer
• Metastatic Breast Cancer
• Metastatic Breast Carcinoma

Intervention

Device:
• Outcomes4Me Mobile App
A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Outcomes4Me	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	12 weeks
Secondary	Measure Net-Promoter Score (NPS) of app usage		12 weeks