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

This study aims to investigate the role of a mobile health app, Outcomes4Me, in the navigation of care for people with breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Metastatic Breast Cancer; Breast Carcinoma; Invasive Breast Cancer; Metastatic Breast Carcinoma
• Intervention / Treatment: Device: Outcomes4Me Mobile App

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 Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Steven Isakoff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Outcomes4Me App Users; This cohort will download and use the Outcomes4Me mobile app for breast cancer.	Device: Outcomes4Me Mobile App; A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	12 weeks
Measure Net-Promoter Score (NPS) of app usage		12 weeks

Collaborators and Investigators

• Sponsor: Outcomes4Me
• Collaborators: Massachusetts General Hospital
• Investigators: Study Chair: Maya Said, Sci.D, Outcomes4Me

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Patient Navigation; Metastatic Breast Cancer; Invasive Breast Cancer; Symptom Management; Treatment Options; NCCN Guidelines; Clinical Trial Options
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: O4M-B001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No