Improving Implementation of Lung Cancer Screening in Diverse Populations II

Not Applicable

Completed

• Conditions: Early Detection of Cancer; Lung Cancer
• Interventions: Other: CAQ

• Registration Number: NCT05265897
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-22
• Last Update Submitted: 2022-02-22
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Has undergone LCS or is referred for LCS
• Able to give informed consent

Read More

Exclusion Criteria

• Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
• Known malignancy other than non-melanoma skin cancer

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAQ	CAQ	Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ)

Primary Outcome Measures

Name	Time	Method
Patient Distress	1 week post-randomization	Symptoms of distress based on Impact of Event Scale (IES)
CAQ Appropriateness and Acceptability	1 week post-randomization	Survey questions soliciting patient opinion of CAQ
Patient Understanding	1 week post-randomization	Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale
Patient Next Step	1 week post-randomization	Correct self-report of next step based on Lung-RADS standardized follow-up

Secondary Outcome Measures

Name	Time	Method
Other Patient Knowledge and Understanding	1 week post-randomization	Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results

Trial Locations

Locations (1)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States