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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03913936
Collaborator
Breast Cancer Research Foundation (Other)
30
1
3
3.9
7.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: YES portal
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Actual Study Start Date :
May 23, 2019
Actual Primary Completion Date :
Sep 19, 2019
Actual Study Completion Date :
Sep 19, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Frequency of logging into the portal. [2 years]

    To measure the number of times participants engage with the portal using log in data collected from back-end of portal.

  2. Time spent in the portal. [2 years]

    To summarize the number of hours/minutes the participant spent using portal through data collected from back-end of portal.

  3. Time spent responding the survey. [2 years]

    To summarize the number of hours/minutes the survey takes to complete through data collected from back-end of portal.

  4. Frequency of information downloads. [2 years]

    To measure the number of times participants download the resource sources provided through data collected from back-end of portal.

  5. Participant-reported utility of the portal. [2 years]

    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.

  6. Participant-reported recommendations for improving the portal. [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dana Farber Cancer Institute Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Ann H. Partridge, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT03913936
Other Study ID Numbers:
  • 18-641
First Posted:
Apr 12, 2019
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2020