Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Lung Cancer
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Nicotine Patch; Other: Tobacco Cessation Counseling; Other: Best Practice

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Robert J. Volk; Phone Number: 713-563-0020; Email: volk@mdanderson.org

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555-0565
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Robert J. Volk; Phone Number: 713-563-0020
      • Principal Investigator: Robert J. Volk
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Robert J. Volk; Phone Number: 713-563-0020
      • Principal Investigator: Robert J. Volk
    • Tyler, Texas, United States, 75708
      • Recruiting
      • University of Texas Health Science Center at Tyler
      • Contact: Robert J. Volk; Phone Number: 713-563-0020
      • Principal Investigator: Robert J. Volk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Patch; Given nicotine patches; Other Names: NicoDerm CQ; Nicotine Skin Patch; Nicotine Transdermal Patch; Other: Tobacco Cessation Counseling; Receive counseling over the phone
Active Comparator: Group II (usual care); Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care counseling; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).	Assessment of the feasibility of implementing the intervention	Up to 12 weeks
Fidelity checklist (11 items)	Assessment of the feasibility of implementing the intervention	Up to 12 weeks
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
Costs of implementing any smoking cessation plus shared decision making intervention	Costs of personnel, hardware, and delivering materials to participants	Up to 12 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Robert J Volk, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: current smoker; health care provider; primary care doctor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2019-0265 (Other Identifier: M D Anderson Cancer Center); NCI-2019-05127 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No