Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
ScreenASSIST
1 other identifier
interventional
642
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2019
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedResults Posted
Study results publicly available
July 23, 2024
CompletedOctober 28, 2024
October 1, 2024
4.8 years
July 27, 2018
May 23, 2024
October 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Self-reported Past 7-day Smoking Abstinence
Number of participants that self-reported no cigarette smoking in the past 7 days
6 Months after enrollment
Secondary Outcomes (4)
Number of Participants With Self-Reported Past 7-day Smoking Abstinence
3 months after enrollment
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
3 Months
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
Study Arms (8)
Short, Short, Present
EXPERIMENTAL4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Short, Long, Present
EXPERIMENTAL4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Long, Short, Present
EXPERIMENTAL8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Long, Long, Present
EXPERIMENTAL8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Short, Short, Absent
EXPERIMENTAL4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Short, Long, Absent
EXPERIMENTAL4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Long, Short, Absent
EXPERIMENTAL8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Long, Long, Absent
EXPERIMENTAL8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Interventions
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Counselor-facilitated referral to a community-based program to address social needs.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham & Women's Faulkner Hospital
Boston, Massachusetts, 02130, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Martha's Vineyard Hospital
Oak Bluffs, Massachusetts, 02557, United States
Salem Hospital
Salem, Massachusetts, 01970, United States
Related Publications (2)
Park ER, Haas JS, Rigotti NA, Neil JM, Marotta CJ, Wint AJ, Gonzalez I, McGovern SE, Chang Y, Levy DE, Flores EJ, Merker VL, Noonan E, Bliss CC. Integrating Tobacco Treatment Into Lung Cancer Screening: The Screen Assist Factorial Randomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):531-539. doi: 10.1001/jamainternmed.2024.8399.
PMID: 40029643DERIVEDPark ER, Neil JM, Noonan E, Howard SE, Gonzalez I, Marotta C, Wint AJ, Levy DE, Chang Y, Rigotti NA, Haas JS. Leveraging the Clinical Timepoints in Lung Cancer Screening to Engage Individuals in Tobacco Treatment. JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac073. doi: 10.1093/jncics/pkac073.
PMID: 36350049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elyse Park, PhD, Professor of Psychiatry and Medicine, Harvard Medical School
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Elyse R Park, PhD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Nancy A Rigotti, MD
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Jennifer Haas, MD, MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
July 27, 2018
First Posted
August 2, 2018
Study Start
April 1, 2019
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
October 28, 2024
Results First Posted
July 23, 2024
Record last verified: 2024-10