Support tool for women with HR+ breast cancer on long-term endocrine therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm pilot study to test the feasibility of enrolling premenopausal women with HR-positive, stage 0–IIIa breast cancer who are on long-term endocrine therapy. The SHIELD portal collects and shares information on symptoms and side effects, and provides self-management resources. Participants will be recruited in-clinic or virtually, use the portal for 3 months, and complete surveys through the platform. Enrollment target is 30 participants, with outcomes focused on feasibility and user engagement. The study is conducted at Dana-Farber Cancer Institute in collaboration with the Breast Cancer Research Foundation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ann H Partridge, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Ann H Partridge, MD, MPH
• Email: ann_partridge@dfci.harvard.edu
• Phone: 617-632-6800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.