search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YES portal
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NEWLY DIAGNOSED

SURVIVOR

LIVING WITH ADVANCED DISEASE

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Frequency of information downloads.
To measure the number of times participants download the resource sources provided through data collected from back-end of portal.
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.
Participant-reported recommendations for improving the portal.
Investigator developed questions asking participants for feedback pertaining to ways to improve the portal and processes.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
March 30, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Breast Cancer Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03913936
Brief Title
Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Official Title
Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Breast Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEWLY DIAGNOSED
Arm Type
Experimental
Arm Description
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
Arm Title
SURVIVOR
Arm Type
Experimental
Arm Description
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
Arm Title
LIVING WITH ADVANCED DISEASE
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
YES portal
Intervention Description
The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
Primary Outcome Measure Information:
Title
Frequency of logging into the portal.
Description
To measure the number of times participants engage with the portal using log in data collected from back-end of portal.
Time Frame
2 years
Title
Time spent in the portal.
Description
To summarize the number of hours/minutes the participant spent using portal through data collected from back-end of portal.
Time Frame
2 years
Title
Time spent responding the survey.
Description
To summarize the number of hours/minutes the survey takes to complete through data collected from back-end of portal.
Time Frame
2 years
Title
Frequency of information downloads.
Description
To measure the number of times participants download the resource sources provided through data collected from back-end of portal.
Time Frame
2 years
Title
Participant-reported utility of the portal.
Description
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.
Time Frame
2 years
Title
Participant-reported recommendations for improving the portal.
Description
Investigator developed questions asking participants for feedback pertaining to ways to improve the portal and processes.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann H. Partridge, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34473546
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs