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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913936
Recruitment Status : Active, not recruiting
First Posted : April 12, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

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
Breast Cancer Other: YES portal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Frequency of logging into the portal. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 2 years ]
    Investigator developed questions asking participants for feedback pertaining to ways to improve the portal and processes.



Information from the National Library of Medicine

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913936


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Breast Cancer Research Foundation
Investigators
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Principal Investigator: Ann H. Partridge, MD Dana-Farber Cancer Institute

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Responsible Party: Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03913936     History of Changes
Other Study ID Numbers: 18-641
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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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, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases