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Recruiting NCT07335354

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RECONJOINT.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Breast Reconstruction Decision Aid (RECONJOINT)

Overview

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.

Interventions

  • Other RECONJOINT
    RECONJOINT is a Breast Reconstruction Decision Aid

Primary outcome measures

  • Feasibility determined by participant accrual [Time frame: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 9 centers
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge
  • Memorial Sloan Kettering Monmouth — Middletown
  • Memorial Sloan Kettering Bergen — Montvale
  • Memorial Sloan Kettering Commack — Commack
  • Memorial Sloan Kettering Westchester — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau — Rockville Centre
  • Duke Cancer Institute (Data collection only) — Durham
  • … and 1 more center

Identifiers

NCT: NCT07335354 · 25-079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗