Clinical trial · Interventional
Implementing BREASTChoice Into Practice
Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
- 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)
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.
Conditions
Conditions (2)
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 Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control Website | Other | — | UNRESOLVED |
| Breast Reconstruction Education and Support Tool (BREASTChoice) | Other | — | UNRESOLVED |
| Clinician Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BREASTChoice
- description
- * After consent, the participant will be randomized * Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message * 1\) prior to their visit with the surgeon; * 2\) at the time of their visit with the surgeon; * 3\) after the surgeon appointment * Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website. * Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
- interventionNames
- Other: Breast Reconstruction Education and Support Tool (BREASTChoice)
- type
- ACTIVE_COMPARATOR
- label
- Attention Control Website
- description
- * After consent, the participant will be randomized * Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message * 1\) prior to their visit with the surgeon; * 2\) at the time of their visit with the surgeon; * 3\) after the surgeon appointment * Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website. * Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Diagnosis of incident or recurrent stage 0-III breast carcinoma Exclusion Criteria: * Stage IV breast carcinoma * Histology type besides ductal/lobular carcinoma (e.g. phyllodes, sarcoma - these rare tumors differ in treatment and prognosis) * Prior mastectomy and are seeking delayed breast reconstruction * No malignancy (i.e., considering mastectomy for prophylaxis only) * Cannot give informed consent or use provided study materials due to self-reported or observed cognitive, visual, or emotional barriers Inclusion Criteria for Clinicians: -Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy Exclusion Criteria for Clinicians: -Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer
References
Publications (0)
Data not yet available