Breast CancerNCT07631026
Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
A study testing Questionnaires in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Philip Hanwright, MD, 713-563-8500, phanwright@mdanderson.org
Philip Hanwright, MD
About this study
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.
Read the detailed description
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. Return to baseline is defined as a 7-day rolling average of daily steps reaching at least 95 percent of the patient's preoperative baseline step average. This objective seeks to establish an objective, quantifiable recovery metric that can serve as a benchmark for postoperative functional recovery in autologous breast reconstruction.
Secondary Objectives:
- Assessing the feasibility and adherence of continuous wearable data collection before and after DIEP flap surgery, including wear time and data completeness.
- Evaluating perioperative trends in heart rate and sleep parameters, and their relationship to overall recovery patterns.
- Exploring associations between wearable-derived recovery metrics (e.g., activity and sleep) and short-term clinical outcomes such as wound complications, seroma, hematoma, DVT/VTE, readmission, and length of stay.
- Comparing wearable activity tracker data with patient-reported activity levels to evaluate agreement between objective and subjective recovery measures.
- Characterizing baseline lifestyle factors - specifically music listening time, active music engagement, and live concert attendance (Gold-MSI Active Engagement subscale) - and exploring their associations with time to return-to-baseline activity, perioperative sleep parameters, and patient-reported outcomes.
- Conditions
- Breast Cancer
- Being tested
- Questionnaires
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
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.
QuestionnairesBehavioural
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.
QuestionnairesBehavioural
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 group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Hanwright, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631026
- Sponsor's protocol ID
- 2026-0053
- Other IDs
- NCI-2026-04196
- Status last verified
- Sep 2026
- First submitted
- 31 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT07631026
- Acronym / sponsor ID
- 2026-0053
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Return to baseline is defined as a 7-day rolling average of daily steps reaching at least 95 percent of the patient's preoperative baseline step average. This objective seeks to establish an objective, quantifiable recovery metric that can serve as a benchmark for postoperative functional recovery in autologous breast reconstruction.
Secondary Objectives:
- Assessing the feasibility and adherence of continuous wearable data collection before and after DIEP flap surgery, including wear time and data completeness.
- Evaluating perioperative trends in heart rate and sleep parameters, and their relationship to overall recovery patterns.
- Exploring associations between wearable-derived recovery metrics (e.g., activity and sleep) and short-term clinical outcomes such as wound complications, seroma, hematoma, DVT/VTE, readmission, and length of stay.
- Comparing wearable activity tracker data with patient-reported activity levels to evaluate agreement between objective and subjective recovery measures.
- Characterizing baseline lifestyle factors - specifically music listening time, active music engagement, and live concert attendance (Gold-MSI Active Engagement subscale) - and exploring their associations with time to return-to-baseline activity, perioperative sleep parameters, and patient-reported outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Behavioral: QuestionnairesEligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPROMIS 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. | Behavioural | All Patients |
| QuestionnairesBREAST-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. | Behavioural | All Patients |
| Questionnaires3-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. | Behavioural | All Patients |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Hanwright, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Hanwright, MD (713-563-8500, phanwright@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.