Lung Cancer Clinical Trial

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Exclusion Criteria:

PATIENTS: History of lung cancer by self-report

Study is for people with:

Lung Cancer

Phase:

Early Phase 1

Estimated Enrollment:

520

Study ID:

NCT04200534

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 3 Locations for this study

See Locations Near You

University of Texas Medical Branch
Galveston Texas, 77555, United States More Info
Robert J. Volk
Contact
713-563-0020
Robert J. Volk
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Robert J. Volk
Contact
713-563-0020
Robert J. Volk
Principal Investigator
University of Texas Health Science Center at Tyler
Tyler Texas, 75708, United States More Info
Robert J. Volk
Contact
713-563-0020
Robert J. Volk
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Early Phase 1

Estimated Enrollment:

520

Study ID:

NCT04200534

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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