Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started May 2019
Shorter than P25 for not_applicable breast-cancer
1 active site
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
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedStudy Start
First participant enrolled
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedApril 24, 2025
April 1, 2025
4 months
February 19, 2019
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
NEWLY DIAGNOSED
EXPERIMENTALParticipants 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
SURVIVOR
EXPERIMENTAL* 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
LIVING WITH ADVANCED DISEASE
EXPERIMENTAL* 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
Interventions
The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Breast Cancer Research Foundationcollaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann H. Partridge, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 19, 2019
First Posted
April 12, 2019
Study Start
May 23, 2019
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- 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
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.