Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Questionnaires; Behavioral: Questionnaires; Behavioral: Questionnaires

Detailed Description

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 and data completeness.
• Evaluating perioperative trends in heart rate and sleep parameters, and their relationship to overall recovery patterns.
• Exploring associations between wearable-derived recovery metrics (e.g., activity and sleep) and short-term clinical outcomes such as wound complications, seroma, hematoma, DVT/VTE, readmission, and length of stay.
• Comparing wearable activity tracker data with patient-reported activity levels to evaluate agreement between objective and subjective recovery measures.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Hanwright, MD; Phone Number: 847) 962-6895; Email: phanwright@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson
      • Contact: Philip Hanwright, MD
      • Principal Investigator: Philip Hanwright, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 activity tracker.
• Significant dermatologic conditions, wound, or allergy preventing safe use of a wrist-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Patients; Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Adverse Events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Philip Hanwright, MD, UT MD Anderson

Publications and helpful links

Helpful Links

• UT MD Anderson Website

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2026-0053; NCI-2026-04196 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No