Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200534
• Other study ID #: 2019-0265
• Secondary ID: NCI-2019-0512720
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 31, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Robert J. Volk
• Phone: 713-563-0020
• Email: volk[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking

Intervention

Other:
• Best Practice
Receive usual care counseling

Drug:
• Nicotine Patch
Given nicotine patches

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Tobacco Cessation Counseling
Receive counseling over the phone

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Cancer Prevention Research Institute of Texas, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence Questionnairre	Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)	Up to 12 weeks
Primary	Lung Cancer Screening 12 items version	Knowledge of lung cancer screening and benefits of smoking cessation	Up to 12 weeks
Secondary	Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study	Assessment of the reach of the intervention	Up to 12 weeks
Secondary	Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).	Assessment of the feasibility of implementing the intervention	Up to 12 weeks
Secondary	Fidelity checklist (11 items)	Assessment of the feasibility of implementing the intervention	Up to 12 weeks
Secondary	EuroQoL-5 dimensions	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.)	Up to 12 weeks
Secondary	Costs of implementing any smoking cessation plus shared decision making intervention	Costs of personnel, hardware, and delivering materials to participants	Up to 12 weeks

External Links

•   University of Texas MD Anderson Cancer Center Website