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Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

NCT07631026 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-27

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Philip Hanwright, MD · UT MD Anderson

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631026 on ClinicalTrials.gov