A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
|
Experimental RCT Participants (Physicians) |
Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio |
|
Recruiting Locations
Basking Ridge, New Jersey 07920
Evan Matros, MD
646-608-8044
Middletown, New Jersey 07748
Evan Matros, MD
646-608-8044
Montvale, New Jersey 07645
Evan Matros, MD
646-608-8044
Commack, New York 11725
Evan Matros, MD
646-608-8044
Harrison, New York 10604
Evan Matros, MD
646-608-8044
New York, New York 10065
Evan Matros, MD
646-608-8044
Rockville Centre, New York 11553
Evan Matros, MD
646-608-8044
Durham, North Carolina 27710
Brett Phillips
888-275-3853
More Details
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center