Breast CancerSHIELDNCT07482384
Supporting Health Including Endocrine Treatment for Long Duration
A study testing SHIELD portal in people with Breast Cancer and Breast Cancer - Female, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer - Female, Breast Carcinoma
- What is being tested?
- SHIELD portal
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Ann H Partridge, MD, MPH, 617-632-6800, ann_partridge@dfci.harvard.edu
Kate Dibble, Ph.D., 617-582-8294, katee_dibble@dfci.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Carcinoma, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Being tested
- SHIELD portal
- Keywords
- Breast cancer, Breast cancer female, Breast carcinoma, ER+, SHIELD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIELD portalBehavioural
Also called Supporting Health Including Endocrine Treatment for Long Duration (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.
| Study group | Role | What they receive |
|---|---|---|
| SHIELD Portal Interventional | Experimental | 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) Receives: Behavioral: SHIELD portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 weeks
Secondary outcomes (3)
Assessment Completion Rate
Assessment completion rate is defined as the proportion of assessments completed to assessments offered.
Measured: Up to 3 months
Patient Information Resources Access Rate
Patient information resources access rate is defined as the proportion of patient information resources accessed to the total number delivered.
Measured: Up to 3 months
SHIELD Portal Access
The number of times the SHIELD portal is accessed per month.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start4 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility single-arm pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Ann H Partridge, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482384
- Sponsor's protocol ID
- 25-771
- Acronym
- SHIELD
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.