Supporting Health Including Endocrine Treatment for Long Duration (SHIELD)

March 16, 2026 updated by: Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute

Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention

This research is being done to pilot an intervention which aims to test a new web- and mobile application ("app")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study is a single-arm intervention pilot study to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease prescribed long-term endocrine treatment. The SHIELD portal is designed to help monitor the frequency and variation in cancer and treatment-related issues and to share self-management information and resources to those interested in particular issues or who indicate a specific concern, symptom or side effect on measures designed to assess and track salient symptoms.

Research study procedures include screening for eligibility, in-clinic and virtual approaches for recruitment, gaining access and using the SHIELD web- and mobile app-based supportive care portal, and completing of survey assessments on the SHIELD portal.

Participation in this research study is expected to last 3 months.

It is expected that 30 people will take part in this research study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

Participants will be eligible if they meet the following eligibility criteria:

  • Female
  • Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer
  • Premenopausal
  • In active treatment (including long-term endocrine therapy) at the time of enrollment
  • Able to speak, understand and read English
  • Access to a US-based mobile phone number
  • Cognitively able to complete study requirements
  • Ability to access medical records from treating hospital (DFCI)
  • Willing to provide cell phone number and/or email address and willing to receive email, mobile push notifications, and/or text messages from the study team

Exclusion criteria

Participants will be ineligible if they meet any of the following criteria:

  • Individuals under age 18 or over age 50 at initial breast cancer diagnosis
  • Patients with breast cancer who are not being treated with ET
  • Stage IV or metastatic breast cancer
  • Pregnant patients
  • Individuals who do not have a US mobile phone number
  • Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHIELD Portal Interventional
320 participants will be enrolled and will complete the following: Baseline visit (assessments) either by in-person clinic visit or virtually Follow-Up/Post Baseline (3-month assessments) Medical record review (if necessary)
Behavioral: SHIELD portal
All participants will receive access to the SHIELD portal. The portal includes educational modules, symptom and side effect tracking, tailored informational resources, and health behavior tools. Participants can access the portal via smartphone, tablet, or computer. The portal is HIPAA compliant and HITRUST certified.
Other Names:
  • Supporting Health Including Endocrine Treatment for Long Duration (SHIELD) Portal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Yield
Time Frame: up to 3 weeks
Enrollment yield is defined as the proportion of participants approached for the study intervention (SHIELD, Supporting Health Including Endocrine Treatment for Long Duration) who enroll.
up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment Completion Rate
Time Frame: Up to 3 months
Assessment completion rate is defined as the proportion of assessments completed to assessments offered.
Up to 3 months
Patient Information Resources Access Rate
Time Frame: Up to 3 months
Patient information resources access rate is defined as the proportion of patient information resources accessed to the total number delivered.
Up to 3 months
SHIELD Portal Access
Time Frame: Up to 3 months
The number of times the SHIELD portal is accessed per month.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Breast Cancer Research Foundation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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