Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Purpose

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

Eligibility

Eligible Ages
Between 55 Years and 77 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Nicotine Patch
    Given nicotine patches
    Other names:
    • NicoDerm CQ
    • Nicotine Skin Patch
    • Nicotine Transdermal Patch
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • 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: Best Practice
    Receive usual care counseling
    Other names:
    • standard of care
    • standard therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555-0565
Contact:
Robert J. Volk
713-563-0020

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Robert J. Volk
713-563-0020
volk@mdanderson.org

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.