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.

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.

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
• Patients with breast cancer who are not being treated with ET
• 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.

Female

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.

Data can be shared no earlier than 1 year following the date of publication.

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu