Wearable Device for Recovery After Breast Reconstruction

PH
Overseen ByPhilip Hanwright, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand patient recovery after breast reconstruction surgery using the DIEP flap technique. Participants will wear a wrist activity tracker, such as a Fitbit, to monitor steps, heart rate, and sleep before and after surgery. Researchers will use the collected data, along with questionnaire responses, to improve future recovery programs and patient counseling. For those with a smartphone scheduled for DIEP flap breast reconstruction, this trial might be suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance recovery experiences for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on tracking recovery with a wearable device, so it's unlikely that your medications would need to change, but you should confirm with the trial organizers.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of wearable devices for monitoring recovery after breast reconstruction, offering a fresh approach to post-surgery care. Unlike standard recovery methods that often rely on intermittent check-ups and self-reported symptoms, this innovative method provides continuous, real-time data through a wearable device. This could lead to more personalized recovery plans and quicker identification of complications, potentially improving outcomes and patient satisfaction. By integrating technology with post-operative care, this approach could revolutionize how recovery is monitored and managed, making it more efficient and tailored to individual needs.

Who Is on the Research Team?

PH

Philip Hanwright, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for people having DIEP flap breast reconstruction surgery, usually after breast cancer. Participants need to be able to wear a wrist activity tracker and complete short questionnaires about their recovery.

Inclusion Criteria

Possession of a compatible smartphone or tablet capable of syncing with the Fitbit Inspire 3 app
I am 18 years old or older.
Willingness to wear the activity tracker continuously for three weeks preoperatively and three months postoperatively
See 2 more

Exclusion Criteria

Participation in another interventional clinical trial that may confound activity or recovery data
I cannot or do not want to wear a wrist activity tracker.
I am planning another major surgery at the same time that could affect my recovery.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Monitoring

Participants' baseline physical activity is measured using the Fitbit Inspire 3 wearable device before surgery

1-2 weeks

Postoperative Monitoring

Participants' recovery is tracked using wearable devices to measure steps, heart rate, and sleep after surgery

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Questionnaires

Trial Overview

Researchers are studying how patients recover from this type of breast reconstruction by tracking physical activity, heart rate, and sleep with a Fitbit device before and after surgery, along with responses to brief surveys.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+