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Improving Implementation of Lung Cancer Screening in Diverse Populations II

Improving Implementation of Lung Cancer Screening in Diverse Populations II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05265897
Enrollment
230
Registered
2022-03-04
Start date
2020-12-01
Completion date
2021-06-30
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Detection of Cancer, Lung Cancer

Keywords

lung cancer screening, low-dose chest CT scan

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.

Interventions

OTHERCAQ

Informational document

Sponsors

American Lung Association
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Understanding1 week post-randomizationRatings of I understand the results of my most recent LCS CT scan on a Likert Scale
Patient Next Step1 week post-randomizationCorrect self-report of next step based on Lung-RADS standardized follow-up
Patient Distress1 week post-randomizationSymptoms of distress based on Impact of Event Scale (IES)
CAQ Appropriateness and Acceptability1 week post-randomizationSurvey questions soliciting patient opinion of CAQ

Secondary

MeasureTime frameDescription
Other Patient Knowledge and Understanding1 week post-randomizationSurvey questions regarding knowledge and understanding of essential components of lung cancer screening and results

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026