Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• UT MD Anderson — Houston

Идентификаторы

NCT: NCT07631026 · 2026-0053 · NCI-2026-04196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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