NCT04262518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

January 30, 2020

Last Update Submit

June 13, 2020

Conditions

Breast CancerInvasive Breast CancerMetastatic Breast CancerBreast CarcinomaMetastatic Breast Carcinoma

Keywords

Invasive Breast CancerMetastatic Breast CancerNCCN GuidelinesPatient NavigationTreatment OptionsClinical Trial OptionsSymptom Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Measure System-Usability Score (SUS) of app usage

    12 weeks

  • Measure Net-Promoter Score (NPS) of app usage

    12 weeks

Study Arms (1)

Outcomes4Me App Users

OTHER

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

Device: Outcomes4Me Mobile App

Interventions

Outcomes4Me Mobile AppDEVICE

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

Outcomes4Me App Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37103597DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maya Said, Sci.D

    Outcomes4Me

    STUDY CHAIR

Central Study Contacts

Amanda Stroiney

CONTACT

860-916-4075amanda@outcomes4me.com

Maya Said, Sci.D

CONTACT

617-794-4963

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 10, 2020

Study Start

June 1, 2020

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)