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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913936
• Other study ID #: 18-641
• Status: Completed
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: September 19, 2019

Study information

• Verified date: March 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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