Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
Overview
- Phase
- Phase 4
- Intervention
- Community Resource
- Conditions
- Smoking, Tobacco
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 642
- Locations
- 6
- Primary Endpoint
- Number of Participants With Self-reported Past 7-day Smoking Abstinence
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Elyse Park, PhD
Associate Professor of Psychiatry
Massachusetts General Hospital
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.
Arms & Interventions
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Community Resource
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Counseling
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Nicotine patch
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Counseling
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Nicotine patch
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Community Resource
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Counseling
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Nicotine patch
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Intervention: Community Resource
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Counseling
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Nicotine patch
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Intervention: Community Resource
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Intervention: Counseling
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Intervention: Nicotine patch
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Intervention: Counseling
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Intervention: Nicotine patch
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Intervention: Counseling
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Intervention: Nicotine patch
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Intervention: Counseling
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Intervention: Nicotine patch
Outcomes
Primary Outcomes
Number of Participants With Self-reported Past 7-day Smoking Abstinence
Time Frame: 6 Months after enrollment
Number of participants that self-reported no cigarette smoking in the past 7 days
Secondary Outcomes
- Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half(6 months)
- Proportion of Patients Who Make an Intentional Attempt to Quit Smoking(3 months)
- Number of Participants With Self-Reported Past 7-day Smoking Abstinence(3 months after enrollment)