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

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: Breast Cancer
• Intervention / Treatment: Other: YES portal

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

3

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.	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.	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.	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.	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.	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.	Investigator developed questions asking participants for feedback pertaining to ways to improve the portal and processes.	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Breast Cancer Research Foundation
• Investigators: Principal Investigator: Ann H. Partridge, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Sella T, Snow C, Freeman H, Poorvu PD, Rosenberg SM, Partridge AH. Young, Empowered and Strong: A Web-Based Education and Supportive Care Intervention for Young Women With Breast Cancer Across the Care Continuum. JCO Clin Cancer Inform. 2021 Aug;5:933-943. doi: 10.1200/CCI.21.00067.

Study record dates

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 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• 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
• product manufactured in and exported from the U.S.: No