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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06118229

Collaborator

(none)

300

Enrollment

Location

15.7

Anticipated Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Device: Wearable smart devices and PROs

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 9, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Postoperative length of hospital stay [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.

Secondary Outcome Measures

Operative time [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patient refusal to participate in this research.
Inability to wear wearable smart monitoring devices due to various reasons.
Pathological reports suggesting non-small cell lung cancer (NSCLC).
History of secondary lung cancer surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China

Sponsors and Collaborators

The First Affiliated Hospital of Guangzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianxing He, Professor, The First Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov Identifier:

NCT06118229

Other Study ID Numbers:

WISP-NSCLC

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jianxing He, Professor, The First Affiliated Hospital of Guangzhou Medical University

Non Small Cell Lung Cancer

Wearable Devices

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 7, 2023