Improving Implementation of Lung Cancer Screening in Diverse Populations II

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Early Detection of Cancer
• Intervention / Treatment: Other: CAQ

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Brief form letter with lung cancer screening results
Experimental: CAQ; Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ)	Other: CAQ; Informational document

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Patient Knowledge and Understanding	Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results	1 week post-randomization

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: American Lung Association
• Investigators: Principal Investigator: Kristina A Cothers, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer screening; low-dose chest CT scan
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SITE00000215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No