NCT04200534

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years – 77 Years
• Healthy volunteers: Accepted

Summary

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

Detailed description

PRIMARY OBJECTIVE: I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening. SECONDARY OBJECTIVES: I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit. II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. After completion of study, participants are followed up at 1, 8, and 12 weeks.

Conditions

• Smoking
• Lung Cancer

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care counseling
DRUG	Nicotine Patch	Given nicotine patches
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Tobacco Cessation Counseling	Receive counseling over the phone

Timeline

• Start date: 2020-07-31
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2019-12-16
• Last updated: 2025-08-22

Locations

3 sites across 1 country: United States