Phase 4
N=642
Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
Smoking, Tobacco
Bottom Line
View on ClinicalTrials.gov: NCT03611881 ↗Enrolled (actual)
642
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Self-reported Past 7-day Smoking Abstinence — 12; 10; 12; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Counseling (Behavioral); Nicotine patch (Drug); Community Resource (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Self-reported Past 7-day Smoking Abstinence |
6; 11; 10; 14; 8; 14 | — |
| SECONDARY Number of Participants With Self-Reported Past 7-day Smoking Abstinence |
6; 11; 10; 14; 8; 14 | — |
| SECONDARY Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half |
21; 23; 23; 26; 19; 21 | — |
| SECONDARY Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half |
21; 23; 23; 26; 19; 21 | — |
| SECONDARY Proportion of Patients Who Make an Intentional Attempt to Quit Smoking |
37; 40; 33; 44; 36; 38 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03611881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.