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Not Yet Recruiting
NCT07631026
Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: M.D. Anderson Cancer Center
Location: UT MD Anderson Houston Texas
Summary
The purpose of this research study is to learn more about how patients recover after DIEP flap breast reconstruction. We will use a wrist worn activity tracker (Fitbit Inspire 3) to measure steps, heart rate, and sleep before and after surgery, and we will compare this information with short questionnaires about your recovery. The information we learn may help improve patient counseling and design future recovery programs.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years.
* Scheduled for delayed\[SH6.1\]\[PH6.2\] unilateral or bilateral DIEP flap breast reconstruction.
* Able and willing to provide informed consent.
* Possession of a compatible smartphone or tablet capable of syncing with the Fitbit Inspire 3 app.
* Willingness to wear the activity tracker continuously for three weeks preoperatively and three months postoperatively.
Exclusion Criteria:
* Inability or unwillingness to wear a wrist-worn or ankle-worn activity tracker.
* Significant dermatologic conditions, wound, or allergy preventing safe use of a wrist-worn or ankle-worn device.
* Planned additional concurrent surgical procedure (non-reconstructive) expected to significantly alter activity level or recovery trajectory (i.e. BSO, CPM).
* Participation in another interventional clinical trial that may confound activity or recovery data.
* Inability to provide informed consent or complete required questionnaires.
Source: ClinicalTrials.gov (NCT07631026). StuddyBuddy aggregates publicly available trial information.