Improving Implementation of Lung Cancer Screening in Diverse Populations II

NCT ID: NCT05265897

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-06-30

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.

Conditions

Early Detection of Cancer; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Usual Care

Brief form letter with lung cancer screening results

Group Type: NO_INTERVENTION

No interventions assigned to this group

CAQ

Usual care, plus "Commonly Asked Questions after Lung Cancer Screening" informational document (CAQ)

Group Type: EXPERIMENTAL

CAQ

Intervention Type: OTHER

Informational document

Interventions

CAQ

Informational document

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kristina Anne Crothers

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina A Cothers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

References

Triplette M, Kross EK, Snidarich M, Shahrir S, Hippe DS, Crothers K. An alternating-intervention pilot trial on the impact of an informational handout on patient-reported outcomes and follow-up after lung cancer screening. PLoS One. 2024 Apr 10;19(4):e0300352. doi: 10.1371/journal.pone.0300352. eCollection 2024.

Reference Type: DERIVED

PMID: 38598511 (View on PubMed)

Other Identifiers

SITE00000215

Identifier Type: -

Identifier Source: org_study_id