Decision tool for people considering breast reconstruction surgery.
Breast Reconstruction Decision Aid (RECONJOINT)
Researchers will try a decision tool called RECONJOINT to help adults with breast cancer or a genetic predisposition decide about post-mastectomy breast reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 131 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT07335354 on ClinicalTrials.gov |
What this trial studies
This is a feasibility project using the RECONJOINT decision aid with both focus groups and a small randomized pilot to determine if a larger trial is practical. Adult patients with a diagnosis of breast cancer or a genetic predisposition who are considering post-mastectomy reconstruction and have a scheduled plastic surgery consultation are eligible to participate. The study will enroll patient focus groups and randomize eligible patients to receive the decision aid versus usual care, tracking recruitment, retention, acceptability, and preliminary decision-related outcomes. Plastic surgeons who perform breast reconstruction frequently will also be enrolled to gather clinician perspectives on using the tool.
Who should consider this trial
Good fit: Adults (≥18) with breast cancer or a known genetic predisposition who are considering post-mastectomy breast reconstruction and have a plastic surgery consultation scheduled are ideal candidates.
Not a fit: People who are not considering post-mastectomy reconstruction or who cannot participate in English are unlikely to receive benefit from this study.
Why it matters
Potential benefit: If successful, the tool could help people better understand reconstruction options and feel more confident and satisfied with their decisions.
How similar studies have performed: Decision aids for surgical choices, including some work in breast reconstruction, have improved patient knowledge and reduced decisional conflict, although RECONJOINT itself is being tested here for feasibility.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau — Rockville Centre, New York, United States (Recruiting)
- Duke Cancer Institute (Data collection only) — Durham, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Evan Matros, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Evan Matros, MD
- Email: matrose@mskcc.org
- Phone: 646-608-8044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.