Supporting Health Including Endocrine Treatment for Long Duration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHIELD portal.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Cancer - Female, Breast Carcinoma, ER Positive Breast Cancer. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention
Overview
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.
Detailed description
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.
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]
Secondary outcome measures (3)
- Assessment Completion Rate [Time frame: Up to 3 months]
- Patient Information Resources Access Rate [Time frame: Up to 3 months]
- SHIELD Portal Access [Time frame: Up to 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT07482384 · 25-771