NCT04824066

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jul 2021Jun 2029

First Submitted

Initial submission to the registry

March 11, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

7.5 years

First QC Date

March 11, 2021

Last Update Submit

May 24, 2026

Conditions

RecoveryTreatment Complication

Outcome Measures

Primary Outcomes (2)

  • Early detection of complications and adverse events using machine learning analysis of patient biometric data.

    Proportion of complications detected by the machine learning algorithm.

    Five Years

  • Prediction of the quality of recovery after treatment using patient biometric data.

    Proportion of patients whose quality of recovery is correctly predicted by the machine learning algorithm.

    Four Years

Study Arms (1)

Treatment Group

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

Device: Device: Wearable Device

Interventions

Device: Wearable DeviceDEVICE

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.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing treatment for benign or malignant conditions that are amenable to wearing a device of interest and meet the inclusion and exclusion criteria above will be approached for informed consent.

You may qualify if:

  • Age 18 years or older
  • 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.
  • Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
  • Individuals willing to provide informed consent and who have capacity for all study procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • Wang D, Fang Z, Zhu A, Rettner B, Potter AL, McCarthy M, Zhang L, Kim J, Zhang Y, Powell J, Pope A, Beqari J, Cranor J, Smock G, Warikoo IM, Aaron A, Guo Q, Hanna G, Mitri J, Zarif M, Melki A, Wilkins I, Lin MW, Lee H, Costantino C, Furlow PW, Sachdeva UM, Auchincloss HG, Wright C, Lanuti M, Li X, Jeffrey Yang CF. Changes in patient-reported quality of life after lobectomy versus sublobar resection. J Thorac Cardiovasc Surg. 2026 Apr;171(4):826-835.e5. doi: 10.1016/j.jtcvs.2025.10.040. Epub 2025 Nov 8.

    PMID: 41213469DERIVED

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Chi-Fu Jeffrey Yang

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Fu Jeffrey Yang, MD

CONTACT

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

Isha Mehta Warikoo, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2021

First Posted

April 1, 2021

Study Start

July 10, 2021

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

US(1)