Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

NCT04200534 | Active Not Recruiting Early Phase 1

• 2 other identifiers: 2019-0265NCI-2019-05127
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Smoking; Lung Cancer

Keywords

current smoker; health care provider; primary care doctor

Outcome Measures

Primary Outcomes (2)

• Smoking abstinence Questionnairre

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

  Up to 12 weeks

• Lung Cancer Screening 12 items version

  Knowledge of lung cancer screening and benefits of smoking cessation

  Up to 12 weeks

Secondary Outcomes (5)

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

  Up to 12 weeks

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

  Up to 12 weeks

• Fidelity checklist (11 items)

  Up to 12 weeks

• EuroQoL-5 dimensions

  Up to 12 weeks

• Costs of implementing any smoking cessation plus shared decision making intervention

  Up to 12 weeks

Study Arms (2)

Group I (centralized care strategy)

EXPERIMENTAL

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.

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

Group II (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care counseling

Also known as: standard of care, standard therapy

Group II (usual care)

Nicotine Patch DRUG

Given nicotine patches

Also known as: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Group I (centralized care strategy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (centralized care strategy); Group II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Group I (centralized care strategy); Group II (usual care)

Tobacco Cessation Counseling OTHER

Receive counseling over the phone

Group I (centralized care strategy)

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PATIENTS: History of lung cancer by self-report

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (3)

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

Related Publications (1)

• Lowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, Maki KG, Kypriotakis G, Leal VB, Shete SS, Fox J, Nishi SP, Cinciripini PM, Volk RJ. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening. Contemp Clin Trials. 2023 May;128:107141. doi: 10.1016/j.cct.2023.107141. Epub 2023 Mar 5.

  PMID: 36878389 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking; Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert J Volk

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: December 16, 2019
• Study Start: July 31, 2020
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-03

Locations

US (3)