About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
SHIELD portal
BehavioralAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Assessment Completion Rate
Assessment completion rate is defined as the proportion of assessments completed to assessments offered.
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.
SHIELD Portal Access
The number of times the SHIELD portal is accessed per month.
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
Breast Cancer Research Foundation
Collaborator