- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720141
Dissemination Of Lung Cancer Screening Education Through Tobacco Quitlines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective/Aim:
Aim 1. Compare two dissemination strategies that vary in intensity on demand for LCS. We hypothesize that there will be a higher demand for LCS in the high-touch strategy arm compared to the low-touch strategy arm, as demonstrated by self-reported LCS completion, as well as scheduling a visit with a health care provider to discuss LCS.
Secondary Objectives/Aim:
Aim 2. Evaluate the impact on reach of the high-touch and low-touch strategies to disseminate LCS educational materials (i.e., view of the decision aid or participation in a decision coaching visit). We expect that disseminating the LCS educational materials through the high-touch strategy will result in higher reach than delivering the LCS educational materials through the low-touch strategy.
Aim 3. Evaluate the financial sustainability and cost-effectiveness of the two approaches of disseminating LCS educational materials. We expect that the high-touch strategy will require a greater financial commitment and stronger partnerships between quitline service providers, state department of health, and health care systems, it will be a cost-effective dissemination strategy compared to the low-touch strategy (emailing/texting).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa Lowenstein, PHD
- Phone Number: (713) 792-5807
- Email: lmlowenstein@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- UT MD Anderson
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Contact:
- Lisa Lowenstein, PHD
- Phone Number: 713-792-5807
- Email: lmlowenstein@mdanderson.org
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Principal Investigator:
- Lisa Lowenstein, PHD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Quitline Client
Quitline client participants must meet the criteria for LCS with regards to age (50 to 80 years) and smoking history (20+ pack-years). This project will not re-confirm quitline client participant eligibility for screening. Tobacco treatment specialists will elicit study interest from only eligible quitline clients.
Representative of the Quitline Community
Representative of the Quitline Community will include any employee of the quitline service provider, representative from an organization that collaborates or funds a tobacco quitline, and/or a representative of the state department of health. All individuals will be adults (18 years and older) and able to speak English.
Representative of the Healthcare Sector
Representative of the healthcare sector will include any adult who works in healthcare, including but not limited to physicians, healthcare administrative leaders/managers, nurses, advanced practice providers. All individuals will be adults (18 years and older) and able to speak English.
Exclusion Criteria:
Not applicable as our focus on quitline clients and representatives (adults) of the quitline community or the healthcare sector.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CMP: Comparator - Low-Touch Strategy (Usual Practice): LCS Educational Resources
Investigators will use a parallel randomized controlled trial to compare a high-touch strategy (emailing/texting + decision coaching + navigation) to a low-touch strategy (emailing/texting) to distribute evidence based LCS educational resources to increase awareness and demand for LCS among quitline clients.
|
Participants will receive the LCS educational materials, decision coaching call for the SDM visit, and navigation for LCS.
|
|
Experimental: INT: Intervention - High-Touch Strategy: LCS Educational Resources, Decision Coaching, Navigation
Investigators will use a parallel randomized controlled trial to compare a high-touch strategy (emailing/texting + decision coaching + navigation) to a low-touch strategy (emailing/texting) to distribute evidence based LCS educational resources to increase awareness and demand for LCS among quitline clients.
|
Participants will receive the LCS educational materials, decision coaching call for the SDM visit, and navigation for LCS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Lowenstein, PHD, UT MD Anderson
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-0714
- NCI-2026-05496 (Other Identifier: NCI-CTRP Clincial Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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