NCT03611881

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 642 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

Detailed description

Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Conditions

• Smoking, Tobacco

Interventions

Type	Name	Description
BEHAVIORAL	Counseling	4 or 8 weeks of behavioral counseling support to promote smoking cessation.
DRUG	Nicotine patch	2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
BEHAVIORAL	Community Resource	Counselor-facilitated referral to a community-based program to address social needs.

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2018-08-02
• Last updated: 2024-10-28
• Results posted: 2024-07-23

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study