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

NCT ID: NCT07335354

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2029-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Focus Group Participants

Participants will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

RECONJOINT/RCT Participants (Patients)

Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care

Group Type EXPERIMENTAL

RECONJOINT

Intervention Type OTHER

RECONJOINT is a Breast Reconstruction Decision Aid

RCT Participants (Physicians)

Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio

Group Type EXPERIMENTAL

RECONJOINT

Intervention Type OTHER

RECONJOINT is a Breast Reconstruction Decision Aid

Interventions

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RECONJOINT

RECONJOINT is a Breast Reconstruction Decision Aid

Intervention Type OTHER

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evan Matros, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Rockville Centre, New York, United States

Site Status RECRUITING

Duke Cancer Institute (Data collection only)

Durham, North Carolina, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Evan Matros, MD

Role: CONTACT

646-608-8044

Carrie Stern, MD

Role: CONTACT

646-608-8048

Facility Contacts

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Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Evan Matros, MD

Role: primary

646-608-8044

Brett Phillips

Role: primary

888-275-3853

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-079

Identifier Type: -

Identifier Source: org_study_id

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