Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

This study is looking at how women recover after a type of breast reconstruction surgery called DIEP flap. Researchers want to understand your recovery by using a Fitbit Inspire 3, a wrist-worn activity tracker, to measure your steps, heart rate, and sleep before and after your surgery. You will also fill out short questionnaires like PROMIS Physical Function v2.0 and BREAST-Q Physical Well-Being to share how you feel. The main goal is to see how long it takes for your physical activity to return to what it was before surgery, using the Fitbit data. This information could help doctors better advise patients and create better recovery programs in the future. Women aged 18 or older who are having delayed unilateral or bilateral DIEP flap breast reconstruction and have a compatible smartphone can join. The study's status is currently unclear.

Study design
This is an interventional study planning to enroll 50 women. It uses questionnaires and a wearable device to track recovery.
What's involved
You will wear a Fitbit Inspire 3 and complete questionnaires before and after your surgery. The study will track your recovery for about one year.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be measured through study completion, which is an average of one year.

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NCT07631026

Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

Not Yet Recruiting
NAAges 18+Interventional
M.D. Anderson Cancer Center
~50 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Questionnaires

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Breast Cancer
1 sites across 1 states
Texas1
  • Philip Hanwright, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson

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Eligibility criteria

Inclusion

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

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.
  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0