Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

NCT03612804 | Completed Results

• 1 other identifier: IIR 16-071
• Study Type: interventional
• Target: 944
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Reduction; Tobacco Use; Tobacco Smoking; Tomography; Lung Diseases; Lung Neoplasms

Keywords

smoking cessation; lung cancer screening; telephone counseling; quitline

Outcome Measures

Primary Outcomes (1)

• Self-reported Smoking Abstinence

  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.

  12 months after lung cancer screening visit

Secondary Outcomes (7)

• Cost of Smoking Cessation Care

  Time period from lung cancer screening through 12 months after lung cancer screening

• Patients' Experience With Telephone Counseling

  3 months after lung cancer screening visit

• Patients' Motivational Assessment

  3 months after lung cancer screening visit

• Patients' Perception of Susceptibility to Harm

  3 months after lung cancer screening visit

• Patients' Self-efficacy Assessment

  3 months after lung cancer screening visit

Study Arms (2)

Unstructured care

NO INTERVENTION

Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.

Proactive care

EXPERIMENTAL

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.

Behavioral: Unsigned note to provider about cessation medication prescription; Behavioral: Proactive Telephone Counseling from VA Quitline

Interventions

Unsigned note to provider about cessation medication prescription BEHAVIORAL

For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.

Proactive care

Proactive Telephone Counseling from VA Quitline BEHAVIORAL

Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.

Proactive care

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Fred Hutchinson Cancer Center: collaborator

Study Sites (3)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Smoking Reduction; Tobacco Use; Tobacco Smoking; Lung Diseases; Lung Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Limitations and Caveats

We originally planned to base our smoking cessation outcome on biochemically-confirmed 7-day smoking abstinence. Due to the COVID-19 pandemic, it was not possible to perform the saliva cotinine testing needed for biochemically confirmed abstinence, and no biochemical data were collected. Instead, we updated our study protocol to use a combination of survey and electronic medical record data to determine smoking status at 12 months post-lung cancer screening as our primary outcome.

Results Point of Contact

• Title: Steven B Zeliadt
• Organization: VA Puget Sound Health Care System

Steven.Zeliadt@va.gov

206-277-4175

Study Officials

• Steven B Zeliadt, PhD MPH

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 2, 2018
• Study Start: May 10, 2019
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified final datasets will be made available through publisher portals or other repositories identified by SCALE collaboration for ensuring dissemination and publication of trial findings upon completion of the study (2022). Preliminary (de-identified) datasets, study protocol, and statistical analysis plans may be made available to other researchers in the SCALE collaboration throughout the duration of the project.
• Access Criteria: Access will only be provided as necessary to allow transparency and evaluation of the results originally obtained by the Principal Investigator who generated the data or to expand upon the work. This assumes the recipient has knowledge, training and resources to adequately design and conduct the studies replicating the original work, or can otherwise determine the validity of results by reviewing the data provided.

Locations

US (3)