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NOT YET RECRUITING
NCT07631026
NA

Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-12-31

Completion Date

2029-12-31

Last Updated

2026-06-05

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Questionnaires

PROMIS Physical Function v2.0: A validated, widely used patient-reported outcome measure assessing perceived physical capability to perform everyday activities. It provides standardized T-scores benchmarked to the general population and is sensitive to changes in postoperative recovery.

BEHAVIORAL

Questionnaires

BREAST-Q Physical Well-Being: Chest and Abdomen Modules: Disease-specific instruments assessing physical comfort, function, and well-being at both the reconstructive (chest) and donor (abdominal) sites. These modules have been validated in autologous reconstruction populations and are sensitive to the functional and symptomatic aspects of DIEP flap recovery.

BEHAVIORAL

Questionnaires

3-Item Recovery Performance Index (RPI): A brief, low-burden instrument that asks patients to report their activity, energy, and overall functional level relative to their individual preoperative baseline. This simple metric complements wearable-derived data by capturing the patient's subjective perception of recovery in these three relevant domains.

Locations (1)

UT MD Anderson

Houston, Texas, United States