Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

NCT07631026 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-0053NCI-2026-04196
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Patients

EXPERIMENTAL

Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

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.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philip Hanwright, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Hanwright, MD

CONTACT

847) 962-6895; phanwright@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

US (1)