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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03535766
Other study ID # 2/2018-014
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 17, 2018
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source St Elizabeth Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2100
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States St. Elizabeth Healthcare Edgewood Kentucky

Sponsors (1)

Lead Sponsor Collaborator
St Elizabeth Healthcare

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Additional time between imaging and physician referrals From identification of concerning nodule to specialist appointment, up to 3 years
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