Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Lung Cancer; Smoking

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Best Practice; Other: Tobacco Cessation Counseling; Drug: Nicotine Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04200534

2019-0265 (Other Identifier)

NCI-2019-05127 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 358 patients

Sex: All

Ages: 55 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

358 participants in 2 patient groups

Group I (centralized care strategy)

Experimental group

Description:

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.

Treatment:

Other: Tobacco Cessation Counseling

Drug: Nicotine Patch

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Group II (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Other: Quality-of-Life Assessment