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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: RECONJOINT

Study type: Interventional

Funder types: Other

Identifiers

NCT07335354

25-079

Details and patient eligibility

About

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.

Enrollment: 131 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

131 participants in 3 patient groups

Focus Group Participants

No Intervention group

Description:

Participants will receive usual care

RECONJOINT/RCT Participants (Patients)

Experimental group

Description:

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

Treatment:

Other: RECONJOINT

RCT Participants (Physicians)

Experimental group

Description:

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

Treatment:

Other: RECONJOINT