Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Early Phase 1

Recruiting

• Conditions: Smoking; Lung Cancer
• Interventions: Other: Best Practice; Drug: Nicotine Patch; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

• Registration Number: NCT04200534
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2020-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• PATIENTS: Primary care patients
• PATIENTS: Upcoming primary care office visit
• PATIENTS: Current smoker
• PATIENTS: 30 plus (+) pack-year smoking history
• PATIENTS: English-speaking
• PROVIDERS: Primary health care providers
• PROVIDERS: Provide care to adults

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Exclusion Criteria

• PATIENTS: History of lung cancer by self-report

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (usual care)	Questionnaire Administration	Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
Group II (usual care)	Best Practice	Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
Group I (centralized care strategy)	Questionnaire Administration	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)	Quality-of-Life Assessment	Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
Group I (centralized care strategy)	Quality-of-Life Assessment	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 I (centralized care strategy)	Tobacco Cessation Counseling	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 I (centralized care strategy)	Nicotine Patch	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.

Primary Outcome Measures

Name	Time	Method
Smoking abstinence Questionnairre	Up to 12 weeks	Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Lung Cancer Screening 12 items version	Up to 12 weeks	Knowledge of lung cancer screening and benefits of smoking cessation

Secondary Outcome Measures

Name	Time	Method
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).	Up to 12 weeks	Assessment of the feasibility of implementing the intervention
Fidelity checklist (11 items)	Up to 12 weeks	Assessment of the feasibility of implementing the intervention
Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study	Up to 12 weeks	Assessment of the reach of the intervention
EuroQoL-5 dimensions	Up to 12 weeks	Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)
Costs of implementing any smoking cessation plus shared decision making intervention	Up to 12 weeks	Costs of personnel, hardware, and delivering materials to participants

Trial Locations

Locations (3)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States