Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

Summary

The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared.

This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive.

Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Smoking Cessation

Interventions

BEHAVIORAL

Questionnaires

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.

PROCEDURE

Low Dose Computed Tomography Scan

Participants have a CT scan of chest to look for signs of lung cancer.

OTHER

Shared Decision Making + Video

Participants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.

BEHAVIORAL

Cessation Counseling

Brief cessation counseling given by LDCT provider.

BEHAVIORAL

Quitline

Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

BEHAVIORAL

Pharmacotherapy Discussion

Participant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.

DRUG

Nicotine Patch

Nicotine patch dispensed. Dosing at physician's discretion.

DRUG

Anti-Smoking Drug

Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.

BEHAVIORAL

Tobacco Treatment Program

Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,

OTHER

Carbon Monoxide (CO) Level Test

Participant asked to blow air through a CO-measuring device.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Pfizer

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jason D Robinson, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-06-16

Primary Completion

2026-06-01

Completion

2026-06-01

FDA Drug

Yes

Countries

• United States

Study Locations