Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

Not Applicable

Completed

• Conditions: Smoking Reduction; Tobacco Use; Tobacco Smoking; Tomography; Lung Diseases; Lung Neoplasms
• Interventions: Behavioral: Unsigned note to provider about cessation medication prescription; Behavioral: Proactive Telephone Counseling from VA Quitline

• Registration Number: NCT03612804
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

Detailed Description

This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Study Timeline

• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2019-05-10
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Results First Submitted: 2024-02-13
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 944

Inclusion Criteria

• Providers who schedule patients for a lung cancer screening at either of the two VA sites.
• Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.

Exclusion Criteria

• Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded.
• Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded.
• Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded.
• Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive care	Unsigned note to provider about cessation medication prescription	Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Proactive care	Proactive Telephone Counseling from VA Quitline	Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.

Primary Outcome Measures

Name	Time	Method
Self-reported Smoking Abstinence	12 months after lung cancer screening visit	The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.

Secondary Outcome Measures

Name	Time	Method
Cost of Smoking Cessation Care	Time period from lung cancer screening through 12 months after lung cancer screening	Costs of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.
Patients' Experience With Telephone Counseling	3 months after lung cancer screening visit	Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.
Patients' Motivational Assessment	12 months after lung cancer screening visit	Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Patients' Perception of Susceptibility to Harm	3 months after lung cancer screening visit	Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees.
Patients' Self-efficacy Assessment	12 months after lung cancer screening visit	Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.

Trial Locations

Locations (3)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States