Clinical trial NCT03611881: Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
Official title: Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking, Tobacco
Keywords: lung screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 642
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Self-reported Past 7-day Smoking Abstinence
timeFrame: 6 Months after enrollment
Secondary outcomes:
measure: Number of Participants With Self-Reported Past 7-day Smoking Abstinence
timeFrame: 3 months after enrollment
measure: Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
timeFrame: 3 Months
measure: Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
timeFrame: 6 months
measure: Proportion of Patients Who Make an Intentional Attempt to Quit Smoking
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Faulkner Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Oak Bluffs
country: United States
facility: Martha's Vineyard Hospital
state: Massachusetts
city: Salem
country: United States
facility: Salem Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elyse R Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Jennifer Haas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: