Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT04824066

Conditions

Recovery

Treatment Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Device: Wearable Device

Study Details

Brief summary:

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-to predict complications and poor recovery in patients undergoing treatment for benign or malignant conditions.

Conditions

Recovery

Treatment Complication

Study ID

NCT04824066

Start date

Jul 10, 2021

Status verified date

May, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older
2. Individuals scheduled to undergo one of the following surgical or non-surgical treatments: cardiothoracic surgery, orthopedic surgery, vascular surgery, colorectal surgery, pancreatic surgery, other major abdominal surgeries, treatment for chronic disease, or systemic therapy (i.e., chemotherapy, immunotherapy, or targeted therapy), radiotherapy, or ablation.
3. Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
4. Individuals willing to provide informed consent and who have capacity for all study procedures

Exclusion Criteria:

1. Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
2. Any pregnant participant.

Study Design

Enrollment

2400 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

Adults patients who are scheduled to undergo treatment for a benign or malignant condition and meet the inclusion and exclusion criteria.

Interventions

Device: Wearable Device

A Wearable Device will be placed on the wrist of the patient \~30 days prior to the patient's scheduled treatment and for up to 5 years following treatment. The device will record activity in terms of steps, sleep quality, heart rate, etc.

Primary outcome measure

  • Early detection of complications and adverse events using machine learning analysis of patient biometric data. [ Time Frame: Five Years ]
  • Prediction of the quality of recovery after treatment using patient biometric data. [ Time Frame: Four Years ]

Central Contacts and Locations

Central contacts

Chi-Fu Jeffrey Yang, MD

617-726-5200cjyang@mgh.harvard.edu

Isha Mehta Warikoo, MD

857-250-1355imehtawarikoo@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Chi-Fu J Yang, M.D.

814-574-8695cjyang@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-28.