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OpenTrials
Completed

NCT Number: NCT05265897

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAQ

Other

Informational document

Primary outcomes

  1. 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

  2. Patient Next Step

    Time frame: 1 week post-randomization

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

  3. Patient Distress

    Time frame: 1 week post-randomization

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

  4. CAQ Appropriateness and Acceptability

    Time frame: 1 week post-randomization

    Survey questions soliciting patient opinion of CAQ

Secondary outcomes

  1. Other Patient Knowledge and Understanding

    Time frame: 1 week post-randomization

    Survey questions regarding knowledge and understanding of essential components of lung cancer screening and results

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • American Lung Association

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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