Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
Sponsored by M.D. Anderson Cancer Center
About this study
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.
Primary Objectives: The primary objective of \[SH1.1\]\[PH1.2\]this study is to determine the time until return to baseline physical activity following DIEP flap breast reconstruction, as measured by the participant's average daily preoperative step count using the Fitbit Inspire 3 wearable device. Return to baseline is defined as a 7-day rolling average of daily steps reaching at least 95 percent of the patient's preoperative baseline step average. This objective seeks to establish an objective, quantifiable recovery metric that can serve as a benchmark for postoperative functional recovery in autologous breast reconstruction. Secondary Objectives: * Assessing the feasibility and adherence of continuous wearable data collection before and after DIEP flap surgery, including wear time an…
Where this study is enrolling
- I'm interested
UT MD Anderson
Houston, Texas
Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.