Clinical trial NCT05046951: Educating QUitline Callers About Lung Cancer Screening
Official title: Testing Methods to Increase Lung Cancer Screening Among Quitline Callers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Population at Risk
Keywords: lung cancer
lung cancer screening
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2021-09-16
Enrollment: 298
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Reach of eligible quitline users
timeFrame: baseline assessment
measure: Intervention Engagement of eligible quitline users
timeFrame: one month assessment
measure: Satisfaction with the intervention materials.
timeFrame: one month assessment
measure: Lung cancer screening knowledge
timeFrame: one month assessment
measure: Lung cancer screening knowledge
timeFrame: four month assessment
measure: Percentage of participants who intend to undergo lung cancer screening
timeFrame: one month assessment
measure: Percentage of participants who intend to undergo lung cancer screening
timeFrame: four month assessment
Secondary outcomes:
measure: Percentage of participants with an appointment for a shared decision making visit
timeFrame: one month assessment
measure: Percentage of participants with an appointment for a shared decision making visit
timeFrame: four month assessment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
References:
citation: 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.