Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07631026
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Questionnaires — BEHAVIORAL
    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.
  • Questionnaires — BEHAVIORAL
    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.
  • Questionnaires — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: All Patients
    Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIP
UT MD AndersonHoustonTexas77030

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UT MD Anderson· Houston, TX

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