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Active Not Recruiting NCT05130580

Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction

Conditions: Breast Carcinoma

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: M.D. Anderson Cancer Center

Location: M D Anderson Cancer Center Houston Texas

Summary

This clinical trial evaluates whether a decision aid application (app) is effective in helping breast reconstruction surgery patients make informed decisions about breast reconstruction surgery. Researchers have created a computer app for breast reconstruction surgery patients that presents images of breast reconstruction outcomes that are customized to the individual patient's treatment options and personal preferences. This decision aid app may help educate patients about how they might look after surgery and answer their questions.

Eligibility Criteria

Inclusion Criteria: * MD Anderson patients, age 21 or older * Planning to undergo either a unilateral or bilateral total, skin-sparing or nipple-sparing mastectomy; or, planning to undergo a unilateral or bilateral modified radical mastectomy * Considering immediate breast reconstruction at MD Anderson * Likely to be a suitable candidate for implant-based reconstruction and/or abdominal-tissue based reconstruction as determined by an MD Anderson Plastic Surgery faculty member * Ambulatory and able to stand unassisted for two minutes (3D imaging system requirement) * Ability to understand and read English without a translator Exclusion Criteria: * Has had a prior consultation with a plastic surgeon to discuss breast reconstruction * History of breast surgery (i.e., breast reduction, mastopexy, segmental mastectomy, augmentation, reconstruction, but not including biopsy) * Planning to have a delayed breast reconstruction * Adjuvant radiation of the breast is indicated at the time of enrollment * Diagnosis consistent with psychosis (such as schizophrenia, schizoaffective disorder, major depressive disorder \[MDD\] with psychotic features or steroid induced psychosis) in the chart * Diagnosis consistent with cognitive impairment such as dementia, cognitive changes with stroke or radiation therapy in the chart * Documented personality disorder * Presence of non-medical tattoo on the breast

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05130580). StuddyBuddy aggregates publicly available trial information.