Clinical trial NCT05265897: Improving Implementation of Lung Cancer Screening in Diverse Populations II
Official title: Improving Implementation of Lung Cancer Screening in Diverse Populations II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Detection of Cancer
Lung Cancer
Keywords: lung cancer screening
low-dose chest CT scan
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2022-03-04
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Understanding
timeFrame: 1 week post-randomization
measure: Patient Next Step
timeFrame: 1 week post-randomization
measure: Patient Distress
timeFrame: 1 week post-randomization
measure: CAQ Appropriateness and Acceptability
timeFrame: 1 week post-randomization
Secondary outcomes:
measure: Other Patient Knowledge and Understanding
timeFrame: 1 week post-randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: University of Washington
name: Kristina A Cothers, MD
role: PRINCIPAL_INVESTIGATOR
References: