Clinical trial · Interventional
A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
Breast Reconstruction Decision Aid (RECONJOINT)
NCT07335354CI-TRIAL-00117438recruitingN/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)
The purpose of this study is to find out whether it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RECONJOINT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Focus Group Participants
- description
- Participants will receive usual care
- type
- EXPERIMENTAL
- label
- RECONJOINT/RCT Participants (Patients)
- description
- Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care
- interventionNames
- Other: RECONJOINT
- type
- EXPERIMENTAL
- label
- RCT Participants (Physicians)
- description
- Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Participant Inclusion Criteria Focus Group Participants * A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record * ≥18 years old * Considering post-mastectomy breast reconstruction RCT Participants (Patients) * A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record * ≥18 years old * Considering post-mastectomy breast reconstruction * Have an appointment scheduled for consultation with a plastic surgery provider RCT Participants (Physicians) * Provides breast reconstruction care ≥ 50% of the time. This is defined as over half of the surgeon's cases in the preceding calendar year being related to breast reconstruction surgery. Participant Exclusion Criteria Focus Group Participants * Not considering post-mastectomy breast reconstruction * Non-English proficiency RCT Participants (Patients) * Not considering postmastectomy breast reconstruction * Recurrent or metastatic breast cancer * Male sex * Non-English proficiency RCT Participants (Physicians) * Does not provide breast reconstruction care at least 50% of the time * Non-English proficiency
References
Publications (0)
Data not yet available
No reference posted for this study.