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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Short, Short, Present 		4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
  • 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.
    Other names:
    • NRT
  • Behavioral: Community Resource
    Counselor-facilitated referral to a community-based program to address social needs.
Experimental
Short, Long, Present 		4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
  • 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.
    Other names:
    • NRT
  • Behavioral: Community Resource
    Counselor-facilitated referral to a community-based program to address social needs.
Experimental
Long, Short, Present 		8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
  • 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.
    Other names:
    • NRT
  • Behavioral: Community Resource
    Counselor-facilitated referral to a community-based program to address social needs.
Experimental
Long, Long, Present 		8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
  • 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.
    Other names:
    • NRT
  • Behavioral: Community Resource
    Counselor-facilitated referral to a community-based program to address social needs.
Experimental
Short, Short, Absent 		4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
  • 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.
    Other names:
    • NRT
Experimental
Short, Long, Absent 		4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
  • 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.
    Other names:
    • NRT
Experimental
Long, Short, Absent 		8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
  • 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.
    Other names:
    • NRT
Experimental
Long, Long, Absent 		8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
  • 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.
    Other names:
    • NRT

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.