Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
- Conditions
- Smoking, Tobacco
- Interventions
- Registration Number
- NCT03611881
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 642
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Short, Short, Absent Counseling 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Short, Short, Absent Nicotine patch 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Short, Long, Absent Counseling 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Short, Short, Present Counseling 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Short, Short, Present Nicotine patch 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Short, Short, Present Community Resource 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Short, Long, Present Counseling 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Short, Long, Present Nicotine patch 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Short, Long, Present Community Resource 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Long, Short, Present Counseling 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Long, Short, Present Nicotine patch 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Long, Short, Present Community Resource 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Long, Long, Present Counseling 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Long, Long, Present Nicotine patch 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Long, Long, Present Community Resource 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Short, Long, Absent Nicotine patch 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Long, Short, Absent Counseling 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Long, Short, Absent Nicotine patch 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Long, Long, Absent Counseling 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Long, Long, Absent Nicotine patch 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
- Primary Outcome Measures
Name Time Method Number of Participants With Self-reported Past 7-day Smoking Abstinence 6 Months after enrollment Number of participants that self-reported no cigarette smoking in the past 7 days
- Secondary Outcome Measures
Name Time Method Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half 6 months Proportion of participants who reduced the number of cigarettes smoked per day in half
Proportion of Patients Who Make an Intentional Attempt to Quit Smoking 3 months Intentional attempt to quit smoking cigarettes that lasts for \>=24 hours
Number of Participants With Self-Reported Past 7-day Smoking Abstinence 3 months after enrollment Number of participants that self-reported no cigarettes smoked in the past 7 days
Trial Locations
- Locations (6)
Salem Hospital
🇺🇸Salem, Massachusetts, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Martha's Vineyard Hospital
🇺🇸Oak Bluffs, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Faulkner Hospital
🇺🇸Boston, Massachusetts, United States