Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment (PROACT)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 944
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010-5011
      • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4734
      • Providence VA Medical Center, Providence, RI
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Unstructured care; Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Experimental: Proactive care; 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: Proactive Telephone Counseling from VA Quitline; 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.; Behavioral: Unsigned note to provider about cessation medication prescription; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of Smoking Cessation Care	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.	Time period from lung cancer screening through 12 months after lung cancer screening
Patients' Experience With Telephone Counseling	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.	3 months after lung cancer screening visit
Patients' Motivational Assessment	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.	3 months after lung cancer screening visit
Patients' Perception of Susceptibility to Harm	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.	3 months after lung cancer screening visit
Patients' Self-efficacy Assessment	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.	3 months after lung cancer screening visit
Patients' Motivational Assessment	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.	12 months after lung cancer screening visit
Patients' Self-efficacy Assessment	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.	12 months after lung cancer screening visit

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Steven B Zeliadt, PhD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): February 9, 2023

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: smoking cessation; lung cancer screening; telephone counseling; quitline
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Lung Neoplasms
• Other Study ID Numbers: IIR 16-071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No