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Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at recovery after DIEP flap surgery, which rebuilds a breast using tissue from the belly. It is for adults scheduled to have this surgery on one or both breasts at a later time, rather than when the breast is removed. The study uses a Fitbit Inspire 3 to track steps, heart rate, and sleep before and after surgery and compares these results with short recovery surveys.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You are scheduled for delayed DIEP flap surgery to rebuild one or both breasts.
  • You can and want to give informed consent, meaning you understand the study and agree to join.
  • You have a smartphone or tablet that can connect to the Fitbit Inspire 3 app.
  • You are willing to wear the tracker all the time for 3 weeks before surgery and 3 months after surgery.

Who can't join

  • You cannot or do not want to wear an activity tracker on your wrist or ankle.
  • You have a skin condition, wound, or allergy that makes wearing the tracker unsafe.
  • You plan to have another surgery at the same time, other than breast reconstruction, that is likely to greatly affect your activity or recovery.
  • You are in another study that tests a treatment or procedure and could affect the activity or recovery results.
  • You cannot give informed consent or complete the required surveys.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

TX