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Active, Not Recruiting

NCT Number: NCT04200534

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

55 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas Medical Branch, Galveston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care counseling

Other names: standard of care, standard therapy

Nicotine patch

Drug

Given nicotine patches

Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Tobacco Cessation Counseling

Other

Receive counseling over the phone

Primary outcomes

  1. Smoking abstinence Questionnairre

    Time frame: Up to 12 weeks

    Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)

  2. Lung Cancer Screening 12 items version

    Time frame: Up to 12 weeks

    Knowledge of lung cancer screening and benefits of smoking cessation

Secondary outcomes

  1. Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study

    Time frame: Up to 12 weeks

    Assessment of the reach of the intervention

  2. Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).

    Time frame: Up to 12 weeks

    Assessment of the feasibility of implementing the intervention

  3. Fidelity checklist (11 items)

    Time frame: Up to 12 weeks

    Assessment of the feasibility of implementing the intervention

  4. EuroQoL-5 dimensions

    Time frame: 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.)

  5. Costs of implementing any smoking cessation plus shared decision making intervention

    Time frame: Up to 12 weeks

    Costs of personnel, hardware, and delivering materials to participants

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Cancer Prevention Research Institute of Texas
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2019
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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