Educating QUitline Callers About Lung Cancer Screening

NCT05046951 | Completed Phase 3

• 1 other identifier: STUDY00002708
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims are:

1. 1.To evaluate the potential barriers of providing educational lung screening interventions to quitline users, the investigators will seek input from 10-20 stakeholders on the newly adapted print version of the Should I Screen website, and on our proposed Aim 2 recruitment and retention procedures.
2. 2.To conduct a randomized intervention, comparing: 1) ShouldIScreen.com website, (WEB; N=150); vs. 2) the Should I Screen print version (PRINT; N=150). H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intention to undergo lung screening, compared to PRINT. Randomization will be stratified by age and pack-years in order to incorporate those who are recently eligible for screening, ages 50-54 and with 20-29 pack years. H2.2 The investigators will explore several potential moderators (age and e-health literacy). For example, the investigators will explore whether older vs younger participants have differential knowledge outcomes when using the PRINT vs WEB interventions. H2.3 We will explore whether mediators (prior lung screening, current primary care provider, lung cancer perceived risk) positively affects knowledge and screening intentions.
3. 3.To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., method of quitline access, age, e-health literacy).

Conditions

Population at Risk

Keywords

lung cancer; lung cancer screening

Outcome Measures

Primary Outcomes (7)

• Reach of eligible quitline users

  % of eligible quitline users enrolled in the trial;

  baseline assessment

• Intervention Engagement of eligible quitline users

  WEB: electronic assessment of 1) logged on, 2) total time spent on website, 3) sections accessed; PRINT: self-reported time spent reading;

  one month assessment

• Satisfaction with the intervention materials.

  Assessment of satisfaction with length, format, and content of the materials

  one month assessment

• Lung cancer screening knowledge

  Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening

  one month assessment

• Lung cancer screening knowledge

  Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening

  four month assessment

• Percentage of participants who intend to undergo lung cancer screening

  Intent to undergo lung cancer screening

  one month assessment

• Percentage of participants who intend to undergo lung cancer screening

  Intent to undergo lung cancer screening

  four month assessment

Secondary Outcomes (2)

• Percentage of participants with an appointment for a shared decision making visit

  one month assessment

• Percentage of participants with an appointment for a shared decision making visit

  four month assessment

Study Arms (2)

Web arm

ACTIVE COMPARATOR

The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.

Behavioral: Should I Screen website

Print Arm

ACTIVE COMPARATOR

The Should I Screen print-based education (included with this IRB protocol) will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.

Behavioral: Should I Screen print booklet

Interventions

Should I Screen website BEHAVIORAL

The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.

Web arm

Should I Screen print booklet BEHAVIORAL

The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.

Print Arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled in the quitline
• years old
• \>20-pack year smoking history
• never screened or \>12 months since prior screen
• English speaking
• able to provide meaningful consent
• no family members in the same household enrolled in the trial
• prior lung cancer

Sponsors & Collaborators

• Georgetown University: lead
• American Lung Association: collaborator

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• Webster M, Whealan J, Williams RM, Eyestone E, Le A, Childs J, Kao JY, Martin M, Wolfe S, Yang F, Hung PY, Lau YK, Luta G, Tammemagi M, Meza R, Taylor KL. The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. Transl Behav Med. 2023 Sep 28;13(10):736-747. doi: 10.1093/tbm/ibad049.

  PMID: 37616531 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: September 16, 2021
• Study Start: May 27, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be availble for one year following the date of publication.
• Access Criteria: Email the corresponding author with the request. Kathryn L. Taylor, taylorkl@georgetown.edu

Locations

US (1)