NCT03535766

Brief Summary

This study is a single center, minimal risk, physician initiated retrospective chart review. An analysis of treatment timelines for patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion. The study investigator and designee(s) will review patient electronic medical records, extracting data related to the symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with data analysis evaluating time between care encounters and potential delays in care. The data will be further stratified based on system-wide changes implemented to improve efficiency, patient outcomes, and patient experience.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2023

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

May 7, 2018

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time from presentation to treatment

    Time from initial patient presentation with symptoms or incidental finding to first day of treatment, measured in days.

    from initial patient presentation with symptoms or incidental finding to first day of treatment, up to 3 years

Secondary Outcomes (1)

  • Additional time between imaging and physician referrals

    From identification of concerning nodule to specialist appointment, up to 3 years

Eligibility Criteria

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

Patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion.

You may qualify if:

  • Patient seen within the St. Elizabeth system
  • \>=18 years of age
  • New diagnosis of histologically or cytologically documented primary lung cancer diagnosed January 2013 or later

You may not qualify if:

  • Patients with metastatic lung disease of other primary
  • Other malignancies at investigator's discretion
  • Patient received treatment at a facility outside of St. Elizabeth where records are not available through EPIC
  • Patient currently undergoing treatment for new diagnosis of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Related Publications (3)

  • Diaconescu R, Lafond C, Whittom R. Treatment delays in non-small cell lung cancer and their prognostic implications. J Thorac Oncol. 2011 Jul;6(7):1254-9. doi: 10.1097/JTO.0b013e318217b623.

    PMID: 21610526BACKGROUND
  • Van de Vosse D, Chowdhury R, Boyce A, Halperin R. Wait Times Experienced by Lung Cancer Patients in the BC Southern Interior to Obtain Oncologic Care: Exploration of the Intervals from First Abnormal Imaging to Oncologic Treatment. Cureus. 2015 Sep 22;7(9):e330. doi: 10.7759/cureus.330.

    PMID: 26543688BACKGROUND
  • Vidaver RM, Shershneva MB, Hetzel SJ, Holden TR, Campbell TC. Typical Time to Treatment of Patients With Lung Cancer in a Multisite, US-Based Study. J Oncol Pract. 2016 Jun;12(6):e643-53. doi: 10.1200/JOP.2015.009605. Epub 2016 May 3.

    PMID: 27143146BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Royce Calhoun, MD

    St Elizabeth Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 24, 2018

Study Start

March 1, 2018

Primary Completion

July 1, 2021

Study Completion

January 9, 2023

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations