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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short, Short, Present | Experimental | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. |
|
| Short, Long, Present | Experimental | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. |
|
| Long, Short, Present | Experimental | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. |
|
| Long, Long, Present | Experimental | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. |
|
| Short, Short, Absent | Experimental | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | 4 or 8 weeks of behavioral counseling support to promote smoking cessation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after enrollment |
| Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham & Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40029643 | Derived | 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. | |
| 39694102 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short, Short, Present | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| FG001 | Short, Long, Present | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| FG002 | Long, Short, Present | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| FG003 | Long, Long, Present | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| FG004 | Short, Short, Absent | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| FG005 | Short, Long, Absent | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| FG006 | Long, Short, Absent | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| FG007 | Long, Long, Absent | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short, Short, Present | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 6 Months after enrollment |
|
Adverse events were collected up to 12 weeks after completion of first counseling session.
Our trial is not an drug trial or intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short, Short, Present | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elyse Park, PhD, Professor of Psychiatry and Medicine, Harvard Medical School | Massachusetts General Hospital | 617.724.6836 | epark@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2024 | May 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D061485 | Tobacco Use Cessation Devices |
| D000091444 | Community Resources |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
| Short, Long, Absent | Experimental | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. |
|
| Long, Short, Absent | Experimental | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. |
|
| Long, Long, Absent | Experimental | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. |
|
| Nicotine patch | Drug | 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
|
|
| Community Resource | Behavioral | Counselor-facilitated referral to a community-based program to address social needs. |
|
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 | 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 | Intentional attempt to quit smoking cigarettes that lasts for >=24 hours | 3 months |
| 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 |
| 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. |
| 36350049 | Derived | 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. |
| BG001 | Short, Long, Present | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| BG002 | Long, Short, Present | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| BG003 | Long, Long, Present | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| BG004 | Short, Short, Absent | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| BG005 | Short, Long, Absent | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| BG006 | Long, Short, Absent | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| BG007 | Long, Long, Absent | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource: Counselor-facilitated referral to a community-based program to address social needs.
| OG002 | Long, Short, Present | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| OG003 | Long, Long, Present | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. |
| OG004 | Short, Short, Absent | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| OG005 | Short, Long, Absent | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| OG006 | Long, Short, Absent | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
| OG007 | Long, Long, Absent | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | Intentional attempt to quit smoking cigarettes that lasts for >=24 hours | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Short, Long, Present | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. | 0 | 82 | 0 | 82 | 0 | 82 |
| EG002 | Long, Short, Present | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG003 | Long, Long, Present | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. Community Resource: Counselor-facilitated referral to a community-based program to address social needs. | 0 | 79 | 0 | 79 | 0 | 79 |
| EG004 | Short, Short, Absent | 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. | 0 | 79 | 0 | 79 | 0 | 79 |
| EG005 | Short, Long, Absent | 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG006 | Long, Short, Absent | 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG007 | Long, Long, Absent | 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. Counseling: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. Nicotine patch: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. | 0 | 78 | 0 | 78 | 0 | 78 |
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| D005159 | Health Care Facilities Workforce and Services |
| D013812 | Therapeutics |
| D004472 | Health Care Economics and Organizations |