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Clinical Trials/NCT05265897
NCT05265897CompletedNot Applicable

Improving Implementation of Lung Cancer Screening in Diverse Populations II

University of Washington2 sites in 1 country230 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
230
Locations
2
Primary Endpoint
Patient Distress

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Patient Distress

Time Frame: 1 week post-randomization

Symptoms of distress based on Impact of Event Scale (IES)

CAQ Appropriateness and Acceptability

Time Frame: 1 week post-randomization

Survey questions soliciting patient opinion of CAQ

Patient Understanding

Time Frame: 1 week post-randomization

Ratings of "I understand the results of my most recent LCS CT scan" on a Likert Scale

Patient Next Step

Time Frame: 1 week post-randomization

Correct self-report of next step based on Lung-RADS standardized follow-up

Secondary Outcomes

  • Other Patient Knowledge and Understanding(1 week post-randomization)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kristina Anne Crothers

Professor, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

University of Washington

Study Sites (2)

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