Clinical trial NCT04200534: Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)
Official title: Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Smoking
Lung Cancer
Keywords: current smoker
health care provider
primary care doctor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Cancer Prevention Research Institute of Texas
First posted: 2019-12-16
Enrollment: 358
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking abstinence Questionnairre
timeFrame: Up to 12 weeks
measure: Lung Cancer Screening 12 items version
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study
timeFrame: Up to 12 weeks
measure: Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).
timeFrame: Up to 12 weeks
measure: Fidelity checklist (11 items)
timeFrame: Up to 12 weeks
measure: EuroQoL-5 dimensions
timeFrame: Up to 12 weeks
measure: Costs of implementing any smoking cessation plus shared decision making intervention
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert J Volk
role: PRINCIPAL_INVESTIGATOR
References: