Educating QUitline Callers About Lung Cancer Screening

NCT ID: NCT05046951

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2022-06-30

Brief Summary

The specific aims are:

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. 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. 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).

Detailed Description

Aim 1: The 30-45 minute qualitative interviews will obtain: 1) feedback on the print adaptation of the Should I Screen website (the investigators will send it in advance of the interview), 2) recommendations for effective recruitment and retention procedures in Aim 2, 3) feedback on methods to increase the likelihood that participants will enroll and engage with the interventions (e.g., whether to present the study information immediately following initial contact with the quitline or later), 4) ideas to increase the likelihood that participants will contact their providers for an appointment to discuss lung screening, and 5) feedback on the Aim 2 measures regarding feasibility and acceptability.

Aim 2: H2.1. At 1- and 4-months post-randomization, the WEB arm will have significantly higher lung screening knowledge and intentions to undergo lung screening, compared to PRINT. H2.2 Moderators include, age, e-health literacy. For example, the investigators expect that younger participants will have significantly increased knowledge in the WEB (vs PRINT) arm, whereas intervention arm will have less of an impact among the older participants. H2.3 Mediators (e.g., prior lung screening, current primary care provider, lung cancer perceived risk) will positively affect knowledge and screening intentions. Aim 3. To evaluate reach (% of quitline users enrolled) and engagement (% who read the intervention materials) by study arm and subgroup (e.g., age, e-health literacy). The investigators will assess the feasibility for widespread implementation of both interventions

Conditions

Population at Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Web arm

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.

Group Type: ACTIVE_COMPARATOR

Should I Screen website

Intervention Type: 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.

Print Arm

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.

Group Type: ACTIVE_COMPARATOR

Should I Screen print booklet

Intervention Type: 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.

Interventions

Should I Screen website

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.

Intervention Type: BEHAVIORAL

Should I Screen print booklet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• enrolled in the quitline
• 50-80 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

Exclusion Criterion:

• prior lung cancer

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgetown University Medical Center

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37616531 (View on PubMed)

Other Identifiers

STUDY00002708

Identifier Type: -

Identifier Source: org_study_id