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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Smoking, Tobacco

Treatments: Behavioral: Community Resource; Drug: Nicotine patch; Behavioral: Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03611881

2018P000539/PHS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 642 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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642 participants in 8 patient groups

Short, Short, Present

Experimental group

Description:

4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.

Treatment:

Behavioral: Counseling

Behavioral: Community Resource

Drug: Nicotine patch

Short, Long, Present

Experimental group

Description:

4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.

Treatment:

Behavioral: Counseling

Behavioral: Community Resource

Drug: Nicotine patch

Long, Short, Present

Experimental group

Description:

8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.

Treatment:

Behavioral: Counseling

Behavioral: Community Resource

Drug: Nicotine patch

Long, Long, Present

Experimental group

Description:

8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.

Treatment:

Behavioral: Counseling

Behavioral: Community Resource

Drug: Nicotine patch

Short, Short, Absent

Experimental group

Description:

4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.

Treatment:

Behavioral: Counseling

Drug: Nicotine patch

Short, Long, Absent

Experimental group

Description:

4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.

Treatment:

Behavioral: Counseling

Drug: Nicotine patch

Long, Short, Absent

Experimental group

Description:

8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.

Treatment:

Behavioral: Counseling

Drug: Nicotine patch

Long, Long, Absent

Experimental group

Description:

8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.

Treatment:

Behavioral: Counseling

Drug: Nicotine patch