Recruiting

SHIELD PortalSupporting Health Including Endocrine Treatment for Long Duration

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07482384

Conditions

Breast Cancer

Breast Cancer - Female

Breast Carcinoma

ER Positive Breast Cancer

PR-Positive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

Interventions

SHIELD portal

Study Details

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.

Conditions

Breast Cancer

Breast Cancer - Female

Breast Carcinoma

ER Positive Breast Cancer

PR-Positive Breast Cancer

Study ID

NCT07482384

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Not accepted

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
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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

Enrollment Yield [ Time Frame: up to 3 weeks ]

Central Contacts and Locations

Central contacts

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

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

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

Breast cancer
Breast cancer female
Breast carcinoma
ER+
SHIELD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-10.