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

NCT ID: NCT04262518

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-10-31

Brief Summary

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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

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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

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Breast Cancer Invasive Breast Cancer Metastatic Breast Cancer Breast Carcinoma Metastatic Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Outcomes4Me App Users

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

Group Type OTHER

Outcomes4Me Mobile App

Intervention Type DEVICE

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

Interventions

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Outcomes4Me Mobile App

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Outcomes4Me

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya Said, Sci.D

Role: STUDY_CHAIR

Outcomes4Me

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Stroiney

Role: CONTACT

860-916-4075

Maya Said, Sci.D

Role: CONTACT

617-794-4963

Facility Contacts

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Steven Isakoff, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37103597 (View on PubMed)

Other Identifiers

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O4M-B001

Identifier Type: -

Identifier Source: org_study_id

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