Smoking, TobaccoPhase 4ScreenASSISTNCT03611881

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

A Phase 4 study testing Counseling, Nicotine patch and Community Resource in people with Smoking, Tobacco, run by Massachusetts General Hospital at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco
What is being tested?: Counseling, Nicotine patch and Community Resource
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 642 participants
Where: 6 sitesUnited States
Study dates: 1 Apr 2019to 31 Jan 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Brigham & Women's Faulkner Hospital
Boston, Massachusetts, 02130
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Martha's Vineyard Hospital
Oak Bluffs, Massachusetts, 02557
Salem Hospital
Salem, Massachusetts, 01970

Other trials in United States

About this study

Official title: Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

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.

Read the 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.

Conditions: Smoking, Tobacco
Being tested: Counseling, Nicotine patch, Community Resource
Keywords: lung screening
Medical subject headings: Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CounselingBehavioural
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patchDrug
Also called NRT
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community ResourceBehavioural
Counselor-facilitated referral to a community-based program to address social needs.

Study groups in NCT03611881
Study group	Role	What they receive
Short, Short, Present	Experimental	4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Community Resource
Short, Long, Present	Experimental	4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Community Resource
Long, Short, Present	Experimental	8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Community Resource
Long, Long, Present	Experimental	8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Community Resource
Short, Short, Absent	Experimental	4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch
Short, Long, Absent	Experimental	4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch
Long, Short, Absent	Experimental	8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch
Long, Long, Absent	Experimental	8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Receives: Behavioral: Counseling; Drug: Nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 Months after enrollment

Secondary outcomes (4)

Number of Participants With Self-Reported Past 7-day Smoking Abstinence
Number of participants that self-reported no cigarettes smoked in the past 7 days
Measured: 3 months after enrollment
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
Proportion of participants who reduced the number of cigarettes smoked per day in half
Measured: 3 Months
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
Proportion of participants who reduced the number of cigarettes smoked per day in half
Measured: 6 months
Proportion of Patients Who Make an Intentional Attempt to Quit Smoking
Intentional attempt to quit smoking cigarettes that lasts for >=24 hours
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201931 Jan 2024

First posted2 Aug 2018
Study start1 Apr 2019
Primary completion31 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03611881
Sponsor's protocol ID: 2018P000539/PHS
Acronym: ScreenASSIST
Status last verified: Oct 2024
First submitted: 27 Jul 2018
Last updated: 28 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 40029643
Avila JC, Flores EJ, Su YJ, Haas JS, Park ER, Rigotti NA. Association of individual and neighborhood socioeconomic status with outcomes of a smoking cessation intervention provided in the lung cancer screening setting. Prev Med. 2025 Feb;191:108207. doi: 10.1016/j.ypmed.2024.108207. Epub 2024 Dec 16.
PubMed 39694102
Park 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.
PubMed 36350049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking, Tobacco trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
ClinicalTrials.gov ID: NCT03611881
Acronym / sponsor ID: ScreenASSIST / 2018P000539/PHS
Conditions: Smoking, Tobacco
Keywords: lung screening
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 642 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 31 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 2 Aug 2018 (actual)
Results: Posted 23 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Short, Short, Present	Experimental	Behavioral: Counseling, Drug: Nicotine patch, Behavioral: Community Resource4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Short, Long, Present	Experimental	Behavioral: Counseling, Drug: Nicotine patch, Behavioral: Community Resource4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Long, Short, Present	Experimental	Behavioral: Counseling, Drug: Nicotine patch, Behavioral: Community Resource8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Long, Long, Present	Experimental	Behavioral: Counseling, Drug: Nicotine patch, Behavioral: Community Resource8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Short, Short, Absent	Experimental	Behavioral: Counseling, Drug: Nicotine patch4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Short, Long, Absent	Experimental	Behavioral: Counseling, Drug: Nicotine patch4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Long, Short, Absent	Experimental	Behavioral: Counseling, Drug: Nicotine patch8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Long, Long, Absent	Experimental	Behavioral: Counseling, Drug: Nicotine patch8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Counseling4 or 8 weeks of behavioral counseling support to promote smoking cessation.	Behavioural	Long, Long, Absent, Long, Long, Present, Long, Short, Absent, Long, Short, Present, Short, Long, Absent, Short, Long, Present, Short, Short, Absent, Short, Short, Present
Nicotine patchAlso: NRT2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.	Drug	Long, Long, Absent, Long, Long, Present, Long, Short, Absent, Long, Short, Present, Short, Long, Absent, Short, Long, Present, Short, Short, Absent, Short, Short, Present
Community ResourceCounselor-facilitated referral to a community-based program to address social needs.	Behavioural	Long, Long, Present, Long, Short, Present, Short, Long, Present, Short, Short, Present

Primary outcome

Number of Participants With Self-reported Past 7-day Smoking Abstinence
Time frame: 6 Months after enrollment
Number of participants that self-reported no cigarette smoking in the past 7 days

4 secondary outcomes

Number of Participants With Self-Reported Past 7-day Smoking Abstinence
Time frame: 3 months after enrollment
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
Time frame: 3 Months
Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half
Time frame: 6 months
Proportion of Patients Who Make an Intentional Attempt to Quit Smoking
Time frame: 3 months

Results and safety

Results posted to the registry on 23 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Short, Short, Present	82	82
Short, Long, Present	82	82
Long, Short, Present	80	80
Long, Long, Present	79	79
Short, Short, Absent	79	79
Short, Long, Absent	81	81
Long, Short, Absent	81	81
Long, Long, Absent	78	78

Primary outcome: Number of Participants With Self-reported Past 7-day Smoking Abstinence

Time frame: 6 Months after enrollment. Count of participants. Unit: Participants

Measure	Short, Short, Present n = 82	Short, Long, Present n = 82	Long, Short, Present n = 80	Long, Long, Present n = 79	Short, Short, Absent n = 79	Short, Long, Absent n = 81	Long, Short, Absent n = 81	Long, Long, Absent n = 78
Value	12	10	12	15	6	10	17	11

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected up to 12 weeks after completion of first counseling session.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Short, Short, Present	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Short, Long, Present	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Long, Short, Present	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Long, Long, Present	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Short, Short, Absent	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Short, Long, Absent	0 of 81 (0%)	0 of 81 (0%)	0 of 81
Long, Short, Absent	0 of 81 (0%)	0 of 81 (0%)	0 of 81
Long, Long, Absent	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40029643Park 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.
Derived from this study: PubMed 39694102Avila JC, Flores EJ, Su YJ, Haas JS, Park ER, Rigotti NA. Association of individual and neighborhood socioeconomic status with outcomes of a smoking cessation intervention provided in the lung cancer screening setting. Prev Med. 2025 Feb;191:108207. doi: 10.1016/j.ypmed.2024.108207. Epub 2024 Dec 16.
Derived from this study: PubMed 36350049Park 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elyse R Park, PhD principal investigator

Massachusetts General Hospital

Nancy A Rigotti, MD principal investigator

Massachusetts General Hospital

Jennifer Haas, MD, MPH principal investigator

Massachusetts General Hospital

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Counseling, Nicotine patch and Community Resource in people with Smoking, Tobacco, run by Massachusetts General Hospital at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Self-reported Past 7-day Smoking Abstinence (time frame: 6 Months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03611881, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.