Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot

March 30, 2023 updated by: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
This research study is piloting a new internet-based research tool (YES portal). The main purpose of this pilot study is to test the web-based interface.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is being done to pilot a web-based research intervention tool. The investigators hope that by piloting it with the participants they can improve the tool and the other processes. The main purpose of this pilot study is to test the web-based interface, the participant's engagement with the platform, and the recruitment procedures. This initial pilot study will inform the design of a larger study intended to monitor common symptoms and behavior, and to provide supportive care information and research opportunities in an iterative manner for young women who have been diagnosed with breast cancer using the YES portal, built for smartphones, tablets, and computers.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Between the ages of 18-44 years
  • A history of breast cancer; we will pilot in 3 separate cohorts consisting of 10 patients each: newly diagnosed patients receiving care at DFCI, prevalent survivors who have completed early active therapy (surgery, chemotherapy and/or radiotherapy) and are being followed at DFCI, and women living with advanced breast cancer receiving care at DFCI
  • Be fluent in and able to read English
  • Have internet access on a regular basis at the time of consent that can support the web-based platform

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEWLY DIAGNOSED

Participants will track their symptoms with weekly and monthly standard surveys to monitor for symptoms.

The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Other: YES portal
The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Experimental: SURVIVOR
  • Participants will track their symptoms with weekly and monthly standard surveys to monitor for symptoms.
  • The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Other: YES portal
The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Experimental: LIVING WITH ADVANCED DISEASE
  • Participants will track their symptoms with weekly and monthly standard surveys to monitor for symptoms.
  • The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Other: YES portal
The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of logging into the portal.
Time Frame: 2 years
To measure the number of times participants engage with the portal using log in data collected from back-end of portal.
2 years
Time spent in the portal.
Time Frame: 2 years
To summarize the number of hours/minutes the participant spent using portal through data collected from back-end of portal.
2 years
Time spent responding the survey.
Time Frame: 2 years
To summarize the number of hours/minutes the survey takes to complete through data collected from back-end of portal.
2 years
Frequency of information downloads.
Time Frame: 2 years
To measure the number of times participants download the resource sources provided through data collected from back-end of portal.
2 years
Participant-reported utility of the portal.
Time Frame: 2 years
Investigator developed questions will be used to assess the utility of the portal including the perceived usefulness of portal in addressing symptoms and needs and ease of use.
2 years
Participant-reported recommendations for improving the portal.
Time Frame: 2 years
Investigator developed questions asking participants for feedback pertaining to ways to improve the portal and processes.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Breast Cancer Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Actual)

September 19, 2019

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication.

IPD Sharing Access Criteria

BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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