Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2027-02-28

Brief Summary

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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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Detailed Description

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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

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Smoking Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I (centralized care strategy)

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 Type EXPERIMENTAL

Nicotine Patch

Intervention Type DRUG

Given nicotine patches

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive counseling over the phone

Group II (usual care)

Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care counseling

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care counseling

Intervention Type OTHER

Nicotine Patch

Given nicotine patches

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Tobacco Cessation Counseling

Receive counseling over the phone

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy NicoDerm CQ Nicotine Skin Patch Nicotine Transdermal Patch Quality of Life Assessment

Eligibility Criteria

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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