Skip to main content
OpenTrials
Completed

NCT Number: NCT03611881

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brigham & Women's Faulkner Hospital, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counseling

Behavioral

4 or 8 weeks of behavioral counseling support to promote smoking cessation.

Nicotine patch

Drug

2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.

Other names: NRT

Community Resource

Behavioral

Counselor-facilitated referral to a community-based program to address social needs.

Primary outcomes

  1. Number of Participants With Self-reported Past 7-day Smoking Abstinence

    Time frame: 6 Months after enrollment

    Number of participants that self-reported no cigarette smoking in the past 7 days

Secondary outcomes

  1. Number of Participants With Self-Reported Past 7-day Smoking Abstinence

    Time frame: 3 months after enrollment

    Number of participants that self-reported no cigarettes smoked in the past 7 days

  2. Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half

    Time frame: 3 Months

    Proportion of participants who reduced the number of cigarettes smoked per day in half

  3. Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half

    Time frame: 6 months

    Proportion of participants who reduced the number of cigarettes smoked per day in half

  4. Proportion of Patients Who Make an Intentional Attempt to Quit Smoking

    Time frame: 3 months

    Intentional attempt to quit smoking cigarettes that lasts for >=24 hours

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

Acronym: ScreenASSIST

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2018
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.