Improving Implementation of Lung Cancer Screening in Diverse Populations II

Lung Cancer Clinical Trial

Official title:

Improving Implementation of Lung Cancer Screening in Diverse Populations II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265897
• Other study ID #: SITE00000215
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project assesses the feasibility, appropriateness, and acceptability of a "Commonly Asked Questions after Lung Cancer Screening" (CAQ) informational document that the investigators created, resulting from patient and provider discussion in focus groups and interviews. If effective, the CAQ may be a new tool to help improve patient understanding of LCS results and adherence to follow-up recommendations.

Description:

Barriers to optimal implementation of lung cancer screening (LCS) include low levels of patient knowledge. Patient understanding of LCS results may alleviate distress and improve understanding of recommendations. The investigators developed a "Commonly Asked Questions after LCS" (CAQ) information sheet based on gaps in knowledge identified by patient focus groups and provider interviews. The study objective was to assess CAQ appropriateness and acceptability, and preliminary impact on patient understanding and distress after receiving LCS results.

The investigators conducted a pilot alternating intervention controlled trial of the CAQ. All patients in the University of Washington/Seattle Cancer Care Alliance LCS program who underwent baseline or annual LCS were received a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus the CAQ (intervention). The mailing assignment was alternated weekly. Mailed follow-up surveys assessed appropriateness and acceptability of CAQ as well as LCS knowledge in the intervention group.

Primary outcomes include: 1) Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale; 2) Correct self-report of next step based on Lung-RADS standardized follow-up; 3) symptoms of distress (measured by IES); as well as 4) measures of acceptability and appropriateness. Secondary outcomes include responses to 6 questions regarding lung cancer screening knowledge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has undergone LCS or is referred for LCS

• Able to give informed consent

Exclusion Criteria:

• Cognitive or language limitations (i.e., expressive language limitations, non-English speaking

• Known malignancy other than non-melanoma skin cancer

Related Conditions & MeSH terms

• Early Detection of Cancer
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• CAQ
Informational document

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Understanding	Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale	1 week post-randomization
Primary	Patient Next Step	Correct self-report of next step based on Lung-RADS standardized follow-up	1 week post-randomization
Primary	Patient Distress	Symptoms of distress based on Impact of Event Scale (IES)	1 week post-randomization
Primary	CAQ Appropriateness and Acceptability	Survey questions soliciting patient opinion of CAQ	1 week post-randomization
Secondary	Other Patient Knowledge and Understanding	Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results	1 week post-randomization