Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

NCT ID: NCT03612804

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2023-02-09

Brief Summary

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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

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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.

Conditions

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Smoking Reduction Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unstructured care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Unsigned note to provider about cessation medication prescription

Intervention Type 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 Telephone Counseling from VA Quitline

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven B Zeliadt, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

New York, New York, United States

Site Status

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

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

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IIR 16-071

Identifier Type: -

Identifier Source: org_study_id

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