Clinical trial · Interventional
Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
NCT07631026CI-TRIAL-00119396not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- description
- Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Safety and Adverse Events (AEs)
- timeFrame
- Through study completion; an average of 1 year
- description
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.