A Study of a Decision Tool for People Considering Breast Reconstruction Surgery (NCT07335354) | Clinical Trial Compass
RecruitingNot Applicable
A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
United States131 participantsStarted 2026-01-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a 'feasibility' study — does that mean its main goal is to test whether the research process itself works, rather than to directly improve my health outcomes, and how should that affect my decision about joining?
2The study involves a decision tool for people considering breast reconstruction surgery — at what point in my treatment timeline would I need to engage with this tool, and could participating affect or delay any decisions I need to make soon about surgery?
3Since this trial is in a 'Not Applicable' phase and is focused on feasibility rather than a treatment itself, what are the potential risks or burdens of participating compared to just having a standard conversation with my surgical team about reconstruction options?
4Would using this decision tool as part of the study give me access to information or support that I wouldn't otherwise get through your regular pre-surgical counseling, or is similar guidance already available to me outside the trial?
5If I'm not sure yet whether I want reconstruction at all, is this trial still relevant for me to consider, or is it better suited for someone who has already decided they want to explore reconstruction??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility determined by participant accrual
Timeframe: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery