NCT06118229

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration 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 Start

First participant enrolled

March 9, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

October 27, 2023

Last Update Submit

June 26, 2024

Conditions

Keywords

Non Small Cell Lung CancerWearable Devices

Outcome Measures

Primary Outcomes (1)

  • Postoperative length of hospital stay

    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 Outcomes (1)

  • Operative time

    From time of the start of surgery to the end of surgery

Study Arms (1)

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

Interventions

Patients wearing wearable smart devices to monitor physiological data while regularly utilizing PROs to report subjective assessments of their own health status.

NSCLC patients wearing wearable smart devices

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patient refusal to participate in this research.
  • Inability to wear wearable smart monitoring devices due to various reasons.
  • History of secondary lung cancer surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jianxing He, M.D

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

March 9, 2023

Primary Completion

July 31, 2024

Study Completion

March 31, 2026

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations