Improving Implementation of Lung Cancer Screening in Diverse Populations II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Implementation of Lung Cancer Screening in Diverse Populations II

Conditions
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Early Detection of Cancer, Lung Cancer

Intervention / Treatment
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* Other: CAQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Alternating intervention controlled trial where treatment assignment was alternated weekly. Participants who underwent baseline or annual lung cancer screening were assigned to receive a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus Commonly Asked Questions informational document (intervention).
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer screening, low-dose chest CT scan