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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: YES portal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEWLY DIAGNOSED<br>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<br>* The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician<br>|
| Experimental: SURVIVOR<br>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<br>* The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician<br>|
| Experimental: LIVING WITH ADVANCED DISEASE<br>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<br>* The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer