Educating QUitline Callers About Lung Cancer Screening

Population at Risk Clinical Trial

— EQUAL  

Official title:

Testing Methods to Increase Lung Cancer Screening Among Quitline Callers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046951
• Other study ID #: STUDY00002708
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2023
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Population at Risk

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	American Lung Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Webster MA, Whealan J, Williams RM, Eyestone E, Le AQ, Childs J, Kao J-Y, Martin M, Wolfe S, Yang F, Hung P-Y, Lau K, Luta G, Tammemagi M, Meza R, Taylor KL (2023). The Tobacco Quitline Setting as a Teachable Moment: The Educating Quitline Users About Lung (EQUAL) Cancer Screening Randomized Trial. Manuscript under review.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of eligible quitline users	% of eligible quitline users enrolled in the trial;	baseline assessment
Primary	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
Primary	Satisfaction with the intervention materials.	Assessment of satisfaction with length, format, and content of the materials	one month assessment
Primary	Lung cancer screening knowledge	Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening	one month assessment
Primary	Lung cancer screening knowledge	Assessment of lung cancer risk factors, screening eligibility, and pros/cons of screening	four month assessment
Primary	Percentage of participants who intend to undergo lung cancer screening	Intent to undergo lung cancer screening	one month assessment
Primary	Percentage of participants who intend to undergo lung cancer screening	Intent to undergo lung cancer screening	four month assessment
Secondary	Percentage of participants with an appointment for a shared decision making visit	Shared decision making appt, lung screening referral, completed lung scan.	one month assessment
Secondary	Percentage of participants with an appointment for a shared decision making visit	Shared decision making appt, lung screening referral, completed lung scan.	four month assessment