Clinical trial · Interventional
Supporting Health Including Endocrine Treatment for Long Duration
Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention
NCT07482384CI-TRIAL-00121164SHIELDrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer - Female | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| ER Positive Breast Cancer | — | UNRESOLVED | — |
| PR-Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHIELD portal | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHIELD Portal Interventional
- description
- 320 participants will be enrolled and will complete the following: Baseline visit (assessments) either by in-person clinic visit or virtually Follow-Up/Post Baseline (3-month assessments) Medical record review (if necessary)
- interventionNames
- Behavioral: SHIELD portal
Primary outcomes (1)
- measure
- Enrollment Yield
- timeFrame
- up to 3 weeks
- description
- 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 (3)
- measure
- Assessment Completion Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.