A Study of a Decision Tool for People Considering Breast Reconstruction Surgery

May 20, 2026 updated by: Memorial Sloan Kettering Cancer Center

Breast Reconstruction Decision Aid (RECONJOINT)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Evan Matros, MD
          • Phone Number: 646-608-8044
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Duke Cancer Institute (Data collection only)
        • Contact:
          • Brett Phillips
          • Phone Number: 888-275-3853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Focus Group Participants
Participants will receive usual care
Experimental: RECONJOINT/RCT Participants (Patients)
Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care
Other: RECONJOINT
RECONJOINT is a Breast Reconstruction Decision Aid
Experimental: RCT Participants (Physicians)
Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio
Other: RECONJOINT
RECONJOINT is a Breast Reconstruction Decision Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility determined by participant accrual
Time Frame: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Evan Matros, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

January 5, 2029

Study Completion (Estimated)

January 5, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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