Clinical trial · Interventional
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
NCT03346161CI-TRIAL-00040415completedPhase 1Results postedClinicalTrials.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)
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.
Conditions
Conditions (1)
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 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Group - Outcome Measures | Other | — | UNRESOLVED |
| Decision tool | Other | — | UNRESOLVED |
| Demographic and Background Questions | Other | — | UNRESOLVED |
| Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" | Other | — | UNRESOLVED |
| Usual Care Group - Outcome Measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: BREASTChoice (Decision Tool)
- description
- Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.
- interventionNames
- Other: Decision tool
- Other: Decision Group - Outcome Measures
- Other: Demographic and Background Questions
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Enhanced Usual Care (Surgical Care Booklet)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
* Newly diagnosed or recurrent breast cancer * Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction * Considering or completing a mastectomy. * Does not have known distant metastatic disease (stage IV disease) at the time of recruitment * Female. * English-speaking. * At least 18 years of age. * Able to understand and willing to sign an IRB-approved written informed consent document.
References
Publications (0)
Data not yet available
No reference posted for this study.