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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focus Group Participants | No Intervention | Participants will receive usual care | |
| RECONJOINT/RCT Participants (Patients) | Experimental | Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care |
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| RCT Participants (Physicians) | Experimental | Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECONJOINT | Other | RECONJOINT is a Breast Reconstruction Decision Aid |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility determined by participant accrual | 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 |
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Participant Inclusion Criteria
Focus Group Participants
RCT Participants (Patients)
RCT Participants (Physicians)
Participant Exclusion Criteria
Focus Group Participants
RCT Participants (Patients)
RCT Participants (Physicians)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evan Matros, MD | Contact | 646-608-8044 | matrose@mskcc.org | |
| Carrie Stern, MD | Contact | 646-608-8048 | sternc2@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Evan Matros, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Memorial Sloan Kettering Monmouth | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Commack | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau | Recruiting | Rockville Centre | New York | 11553 | United States |
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| Duke Cancer Institute (Data collection only) | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| Duke Cancer Institute (Data collection only) | Recruiting | Durham | North Carolina | 27710 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |