NCT07482384 · Dana-Farber Cancer Institute
Supporting Health Including Endocrine Treatment for Long Duration
(SHIELD)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants will be eligible if they meet the following eligibility criteria:
- 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
- Boston, Massachusetts
Collaborators
Breast Cancer Research Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations