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

• ClinicalTrials.gov Identifier: NCT03611881
• Recruitment Status: Recruiting
• First Posted: August 2, 2018
• Last Update Posted: April 16, 2019
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Elyse Park, PhD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: July 27, 2018
• First Posted Date: August 2, 2018
• Last Update Posted Date: April 16, 2019
• Actual Study Start Date: April 8, 2019
• Estimated Primary Completion Date: February 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03611881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Smoking, Tobacco

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 27, 2018): 720
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2023
• Estimated Primary Completion Date: February 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 55 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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: United States

Administrative Information

• NCT Number: NCT03611881
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Elyse Park, PhD, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• 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