Supporting Health Including Endocrine Treatment for Long Duration
SHIELD
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
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 2026
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 19, 2026
March 1, 2026
8 months
March 16, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Enrollment Yield
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 Outcomes (3)
Assessment Completion Rate
Up to 3 months
Patient Information Resources Access Rate
Up to 3 months
SHIELD Portal Access
Up to 3 months
Study Arms (1)
SHIELD Portal Interventional
EXPERIMENTAL320 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
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, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 19, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
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
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.