Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
2026年9月15日 更新者：M.D. Anderson Cancer Center
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.
研究概览
详细说明
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.
- Characterizing baseline lifestyle factors - specifically music listening time, active music engagement, and live concert attendance (Gold-MSI Active Engagement subscale) - and exploring their associations with time to return-to-baseline activity, perioperative sleep parameters, and patient-reported outcomes.
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Philip Hanwright, MD
- 电话号码：713-563-8500
- 邮箱：phanwright@mdanderson.org
学习地点
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Texas
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Houston、Texas、美国、77030
- UT MD Anderson
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首席研究员：
- Philip Hanwright, MD
-
接触：
- Philip Hanwright, MD
- 电话号码：713-563-8500
- 邮箱：phanwright@mdanderson.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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 or ankle-worn activity tracker.
- Significant dermatologic conditions, wound, or allergy preventing safe use of a wrist-worn or ankle-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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：All Patients
Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.
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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.
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.
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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安全性和不良事件 (AE)
大体时间：通过学习完成；平均1年
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不良事件发生率，根据美国国家癌症研究所不良事件通用术语标准 (NCI CTCAE) 版本 (v) 5.0 进行分级
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通过学习完成；平均1年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Philip Hanwright, MD、UT MD Anderson
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月31日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年5月31日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.