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Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

NCT07631026

Not Yet RecruitingNA

Sponsor: M.D. Anderson Cancer Center

Conditions: Breast Cancer

Interventions: Questionnaires, Questionnaires, Questionnaires

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Houston, Texas, United States