A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
Breast Reconstruction Decision Aid (RECONJOINT)
1 other identifier
interventional
131
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2026
Typical duration for not_applicable breast-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2026
CompletedStudy Start
First participant enrolled
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 5, 2029
January 13, 2026
January 1, 2026
3 years
January 5, 2026
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility determined by participant accrual
Determine the feasibility of a hybrid effectiveness-implementation study that investigates the effectiveness and implementation potential of a decision aid to improve shared decision-making in breast reconstruction.
<60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery
Study Arms (3)
Focus Group Participants
NO INTERVENTIONParticipants will receive usual care
RECONJOINT/RCT Participants (Patients)
EXPERIMENTALParticipants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care
RCT Participants (Physicians)
EXPERIMENTALParticipating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio
Interventions
RECONJOINT is a Breast Reconstruction Decision Aid
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553, United States
Duke Cancer Institute (Data collection only)
Durham, North Carolina, 27710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Matros, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 13, 2026
Study Start
January 5, 2026
Primary Completion (Estimated)
January 5, 2029
Study Completion (Estimated)
January 5, 2029
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.