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Clinical Trials/NCT05046951
NCT05046951
Completed
Phase 3

Testing Methods to Increase Lung Cancer Screening Among Quitline Callers

Georgetown University1 site in 1 country298 target enrollmentMay 27, 2021

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Population at Risk
Sponsor
Georgetown University
Enrollment
298
Locations
1
Primary Endpoint
Intervention Engagement of eligible quitline users
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 27, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intervention Engagement of eligible quitline users

Time Frame: one month assessment

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

Reach of eligible quitline users

Time Frame: baseline assessment

% of eligible quitline users enrolled in the trial;

Satisfaction with the intervention materials.

Time Frame: one month assessment

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

Lung cancer screening knowledge

Time Frame: four month assessment

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

Percentage of participants who intend to undergo lung cancer screening

Time Frame: four month assessment

Intent to undergo lung cancer screening

Secondary Outcomes

  • Percentage of participants with an appointment for a shared decision making visit(four month assessment)

Study Sites (1)

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