A Study to Explore the Role and Impact of Wearable Smart Devices in Perioperative NSCLC Patients

June 26, 2024 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

A Prospective Observational Study to the Role and Impact of Wearable Smart Devices in Perioperative NSCLC Patients

The trial was designed as a single-center non-interventional prospective observational study to explore the role and impact of wearable smart devices in perioperative NSCLC patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
          • Wenhua Liang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Continuously enroll all patients with non-small cell lung cancer, histopathologically confirmed

Description

Inclusion Criteria:

  1. Participants must provide voluntary consent to participate in this research and possess the capacity to sign an informed consent form.
  2. Participants must be aged over 18 years.
  3. Participants must have undergone pulmonary resection surgery with a postoperative pathological confirmation of primary lung cancer.

Exclusion Criteria:

  1. Patient refusal to participate in this research.
  2. Inability to wear wearable smart monitoring devices due to various reasons.
  3. The pathological report suggests a non-small cell lung cancer (NSCLC) exclusion.
  4. History of secondary lung cancer surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NSCLC patients wearing wearable smart devices
NSCLC patients wearing wearable smart devices while utilizing PROs for regular follow-up
Device: Wearable smart devices and PROs
Patients wearing wearable smart devices to monitor physiological data while regularly utilizing PROs to report subjective assessments of their own health status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: From time of surgery to time of discharge from the hospital (assessed up to 30 days)
Postoperative Length of Stay (LOS) refers to the duration of a patient's hospitalization following surgery, typically measured from the completion of the surgical procedure to the time of patient discharge.
From time of surgery to time of discharge from the hospital (assessed up to 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: From time of the start of surgery to the end of surgery
Operative time is defined as the time from the start of the surgical procedure to its completion, including anesthesia induction, surgical incision, manipulation of tissues, closure, and completion of all surgical tasks.
From time of the start of surgery to the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Jianxing He, M.D, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WISP-NSCLC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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