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Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS) (ScreenASSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611881
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 27, 2018
First Posted Date  ICMJE August 2, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 6 Months ]
Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Self-reported past 7-day smoking abstinence [ Time Frame: 3 months after enrollment ]
    Patient self-report of no cigarettes smoked in the past 7 days
  • Self-reported past 7-day smoking abstinence [ Time Frame: 6 months after enrollment ]
    Patient self-report of no cigarette smoking in the past 7 days
  • Proportion of patients with >50% reduction in cigarettes smoked per day [ Time Frame: 3 Months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up
  • Proportion of patients with >50% reduction in cigarettes smoked per day [ Time Frame: 6 months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up
  • Proportion of patients who make an intentional attempt to quit smoking [ Time Frame: 3 months ]
    Intentional attempt to quit smoking cigarettes that lasts for >=24 hours
  • Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 3 Months ]
    Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Self-reported past 7-day smoking abstinence [ Time Frame: 3 months after enrollment ]
    Patient self-report of no cigarettes smoked in the past 7 days
  • Self-reported past 7-day smoking abstinence [ Time Frame: 6 months after enrollment ]
    Patient self-report of no cigarette smoking in the past 7 days
  • Significant smoking reduction [ Time Frame: 3 Months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up
  • Significant smoking reduction [ Time Frame: 6 months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up
  • Attempt to quit smoking [ Time Frame: 3 months ]
    Intentional attempt to quit smoking cigarettes that lasts for >=24 hours
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
Official Title  ICMJE Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
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. Patients who self-report 7-day abstinence at 3- and 6- months follow-up will be asked to provide a saliva sample to assay for cotinine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking, Tobacco
Intervention  ICMJE
  • Behavioral: Counseling
    4 or 8 weeks of behavioral counseling support to promote smoking cessation.
  • Drug: Nicotine patch
    2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
    Other Name: NRT
  • Behavioral: Community Resource
    Counselor-facilitated referral to a community-based program to address social needs.
Study Arms  ICMJE
  • Experimental: Short, Short, Present
    4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
    • Behavioral: Community Resource
  • Experimental: Short, Long, Present
    4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
    • Behavioral: Community Resource
  • Experimental: Long, Short, Present
    8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
    • Behavioral: Community Resource
  • Experimental: Long, Long, Present
    8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
    • Behavioral: Community Resource
  • Experimental: Short, Short, Absent
    4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
  • Experimental: Short, Long, Absent
    4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
  • Experimental: Long, Short, Absent
    8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
  • Experimental: Long, Long, Absent
    8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
    Interventions:
    • Behavioral: Counseling
    • Drug: Nicotine patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled to undergo LDCT-LCS at a participating Partners 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 55-80 years, 30+ pack/years).

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elyse R Park, Ph.D. (617) 724-6836 epark@mgh.harvard.edu
Contact: Saif Hawari, MB, BCh, BAO (617) 726-3261 shawari@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03611881
Other Study ID Numbers  ICMJE 2018P000539/PHS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elyse Park, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elyse R Park, PhD Massachusetts General Hospital
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Principal Investigator: Jennifer Haas, MD, MPH Brigham and Women's Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP