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

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had eight arms (groups): Short, Short, Present (experimental), Short, Long, Present (experimental), Long, Short, Present (experimental), Long, Long, Present (experimental) and Short, Short, Absent (experimental).

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

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

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

The registry classes the interventions as behavioral and drug.

More on the Plan

Nicotine patch is an FDA-approved cessation aid.

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.

Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Who Took Part

Enrollment: 642 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, factorial and open-label study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2019-04-01 with completion listed for 2024-01-31.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Self-reported Past 7-day Smoking Abstinence (time frame: 6 Months after enrollment).

It also tracked 4 secondary outcomes, for example Number of Participants With Self-Reported Past 7-day Smoking Abstinence and Proportion of Patients Who Make an Intentional Attempt to Quit Smoking.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 642 people.

With 642 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.