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

Primary Purpose

Breast Cancer, Invasive Breast Cancer, Metastatic Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Outcomes4Me Mobile App

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Invasive Breast Cancer, Metastatic Breast Cancer, NCCN Guidelines, Patient Navigation, Treatment Options, Clinical Trial Options, Symptom Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Outcomes4Me App Users

Arm Description

This cohort will download and use the Outcomes4Me mobile app for breast cancer.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Measure Net-Promoter Score (NPS) of app usage

Full Information

NCT ID

NCT04262518

First Posted

January 30, 2020

Last Updated

June 13, 2020

Sponsor

Outcomes4Me

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04262518

Brief Title

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

Acronym

FIONA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Outcomes4Me

Collaborators

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Outcomes4Me App Users

Arm Type

Other

Arm Description

This cohort will download and use the Outcomes4Me mobile app for breast cancer.

Intervention Type

Device

Intervention Name(s)

Outcomes4Me Mobile App

Intervention Description

A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer

Primary Outcome Measure Information:

Title

Measure # of times a patient logs into the Outcomes4Me app over a 12 week period

Description

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Measure System-Usability Score (SUS) of app usage

Description

Time Frame

12 weeks

Title

Measure Net-Promoter Score (NPS) of app usage

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amanda Stroiney

Phone

860-916-4075

amanda@outcomes4me.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maya Said, Sci.D

Phone

617-794-4963

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maya Said, Sci.D

Organizational Affiliation

Outcomes4Me

Official's Role

Study Chair

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Isakoff, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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