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

Smoking, Tobacco Clinical Trial

— ScreenASSIST  

Official title:

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611881
• Other study ID #: 2018P000539/PHS
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Scheduled to undergo LDCT-LCS at a participating Mass General Brigham Health Care System LCS site

• Speak English or Spanish.

• Current smokers: smoked a cigarette, even a puff, in the last 30 days.

• Medicare coverage requirement (age 50-80 years, 20+ pack/years).

• Residing within the USA.

Exclusion Criteria:

• Undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation.

• Unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study PI or treating clinician.

• No access to a telephone or cannot communicate by telephone.

Related Conditions & MeSH terms

• Smoking, Tobacco

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham & Women's Faulkner Hospital	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Martha's Vineyard Hospital	Oak Bluffs	Massachusetts
United States	Salem Hospital	Salem	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemically-verified past 7-day abstinence from cigarette smoking	Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.	6 Months - no longer in use after 7/6/2020
Other	Biochemically-verified past 7-day abstinence from cigarette smoking	Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.	3 Months - no longer in use after 7/6/2020
Primary	Self-reported past 7-day smoking abstinence	Patient self-report of no cigarette smoking in the past 7 days	6 Months after enrollment
Secondary	Self-reported past 7-day smoking abstinence	Patient self-report of no cigarettes smoked in the past 7 days	3 months after enrollment
Secondary	Proportion of patients with >50% reduction in cigarettes smoked per day	>50% decrease in cigarettes smoked per day between baseline and follow-up	3 Months
Secondary	Proportion of patients with >50% reduction in cigarettes smoked per day	>50% decrease in cigarettes smoked per day between baseline and follow-up	6 months
Secondary	Proportion of patients who make an intentional attempt to quit smoking	Intentional attempt to quit smoking cigarettes that lasts for >=24 hours	3 months