Improving Implementation of Lung Cancer Screening in Diverse Populations II

NCT05265897 | Completed

• 1 other identifier: SITE00000215
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Detection of Cancer; Lung Cancer

Keywords

lung cancer screening; low-dose chest CT scan

Outcome Measures

Primary Outcomes (4)

• Patient Understanding

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

  1 week post-randomization

• Patient Next Step

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

  1 week post-randomization

• Patient Distress

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

  1 week post-randomization

• CAQ Appropriateness and Acceptability

  Survey questions soliciting patient opinion of CAQ

  1 week post-randomization

Secondary Outcomes (1)

• Other Patient Knowledge and Understanding

  1 week post-randomization

Study Arms (2)

Usual Care

NO INTERVENTION

Brief form letter with lung cancer screening results

CAQ

EXPERIMENTAL

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

Other: CAQ

Interventions

CAQ OTHER

Informational document

CAQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has undergone LCS or is referred for LCS
• Able to give informed consent

You may not qualify if:

• Cognitive or language limitations (i.e., expressive language limitations, non-English speaking
• Known malignancy other than non-melanoma skin cancer

Sponsors & Collaborators

• University of Washington: lead
• American Lung Association: collaborator

Study Sites (1)

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 38598511 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kristina A Cothers, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

Model Details: 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).

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 4, 2022
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

US (1)