Clinical trial NCT03315910: Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
Official title: Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Tobacco Treatment
Lung CT
Cancer Screening
17-500
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-10-20
Enrollment: 807
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators have chosen to conduct a full factorial experimental design.
Primary purpose: PREVENTION

Brief summary: This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.


Eligibility criteria: Inclusion Criteria:

Site Eligibility (as per SC self-report)

\& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site

* Reports at least one year of lung cancer screening experience
* Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
* Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
* Between the ages of 50-80 years old
* Seeking baseline or annual follow-up LDCT lung cancer screening
* Have at least a 20 pack-year history of smoking
* Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
* Must be reachable by telephone
* Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.

Exclusion Criteria:

Patient (as per self-report)

* NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
* Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.

Primary outcomes:
measure: number of patients who are tobacco abstinence
timeFrame: 6 months following study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: John Muir Health
state: California
city: LaGrange
country: United States
facility: WellStar Health System
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kankakee
country: United States
facility: Riverside Healthcare
state: Illinois
city: Crown Point
country: United States
facility: St. Mary Medical Center, Community Healthcare System
state: Indiana
city: Des Moines
country: United States
facility: MercyOne Des Moines Medical Center (Data Collection Only)
state: Iowa
city: Scarborough
country: United States
facility: Maine Medical Center Cancer Institute
state: Maine
city: Detroit
country: United States
facility: Henry Ford Hospital (Data collection only)
state: Michigan
city: Traverse City
country: United States
facility: Munson Healthcare
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center (Data Collection Only)
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Morganton
country: United States
facility: Carolinas Healthcare System Blue Ridge
state: North Carolina
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Portland
country: United States
facility: Legacy Health
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostroff JS, Shelley DR, Chichester LA, King JC, Li Y, Schofield E, Ciupek A, Criswell A, Acharya R, Banerjee SC, Elkin EB, Lynch K, Weiner BJ, Orlow I, Martin CM, Chan SV, Frederico V, Camille P, Holland S, Kenney J. Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings. Trials. 2022 Aug 17;23(1):664. doi: 10.1186/s13063-022-06568-3.