Smoking, Tobacco
Conditions
Keywords
lung 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.
Interventions
BEHAVIORALCounseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
DRUGNicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
BEHAVIORALCommunity Resource
Counselor-facilitated referral to a community-based program to address social needs.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Past 7-day Smoking Abstinence | 6 Months after enrollment | Number of participants that self-reported no cigarette smoking in the past 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 3 months after enrollment | Number of participants that self-reported no cigarettes smoked in the past 7 days |
| 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 Patients Who Make an Intentional Attempt to Quit Smoking | 3 months | Intentional attempt to quit smoking cigarettes that lasts for \>=24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| 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. | 82 |
| 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. | 80 |
| 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. | 79 |
| 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. | 79 |
| 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. | 81 |
| 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. | 81 |
| 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. | 78 |
| Total | 642 |
Baseline characteristics
| Characteristic | Short, Short, Present | Short, Long, Present | Long, Short, Present | Long, Long, Present | Short, Short, Absent | Short, Long, Absent | Long, Short, Absent | Long, Long, Absent | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 33 Participants | 40 Participants | 32 Participants | 29 Participants | 36 Participants | 32 Participants | 30 Participants | 265 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 40 Participants | 47 Participants | 50 Participants | 45 Participants | 49 Participants | 48 Participants | 377 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 5 Participants | 6 Participants | 2 Participants | 8 Participants | 7 Participants | 7 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 73 Participants | 73 Participants | 72 Participants | 70 Participants | 69 Participants | 72 Participants | 67 Participants | 571 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 7 Participants | 4 Participants | 2 Participants | 4 Participants | 24 Participants |
| Language English | 78 Participants | 80 Participants | 79 Participants | 76 Participants | 78 Participants | 77 Participants | 78 Participants | 75 Participants | 621 Participants |
| Language Spanish | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 6 Participants | 10 Participants | 9 Participants | 8 Participants | 7 Participants | 6 Participants | 7 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 1 Participants | 4 Participants | 0 Participants | 3 Participants | 4 Participants | 5 Participants | 21 Participants |
| Race (NIH/OMB) White | 65 Participants | 72 Participants | 67 Participants | 63 Participants | 70 Participants | 68 Participants | 70 Participants | 65 Participants | 540 Participants |
| Sex: Female, Male Female | 44 Participants | 43 Participants | 40 Participants | 47 Participants | 48 Participants | 51 Participants | 50 Participants | 35 Participants | 358 Participants |
| Sex: Female, Male Male | 38 Participants | 39 Participants | 40 Participants | 32 Participants | 31 Participants | 30 Participants | 31 Participants | 43 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 82 | 0 / 80 | 0 / 79 | 0 / 79 | 0 / 81 | 0 / 81 | 0 / 78 |
| other Total, other adverse events | 0 / 82 | 0 / 82 | 0 / 80 | 0 / 79 | 0 / 79 | 0 / 81 | 0 / 81 | 0 / 78 |
| serious Total, serious adverse events | 0 / 82 | 0 / 82 | 0 / 80 | 0 / 79 | 0 / 79 | 0 / 81 | 0 / 81 | 0 / 78 |
Outcome results
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
Time frame: 6 Months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short, Short, Present | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 12 Participants |
| Short, Long, Present | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 10 Participants |
| Long, Short, Present | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 12 Participants |
| Long, Long, Present | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 15 Participants |
| Short, Short, Absent | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 6 Participants |
| Short, Long, Absent | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 10 Participants |
| Long, Short, Absent | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 17 Participants |
| Long, Long, Absent | Number of Participants With Self-reported Past 7-day Smoking Abstinence | 11 Participants |
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
Time frame: 3 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short, Short, Present | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 6 Participants |
| Short, Long, Present | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 11 Participants |
| Long, Short, Present | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 10 Participants |
| Long, Long, Present | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 14 Participants |
| Short, Short, Absent | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 8 Participants |
| Short, Long, Absent | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 14 Participants |
| Long, Short, Absent | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 12 Participants |
| Long, Long, Absent | Number of Participants With Self-Reported Past 7-day Smoking Abstinence | 7 Participants |
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
Time frame: 3 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short, Short, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 21 Participants |
| Short, Long, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 24 Participants |
| Long, Short, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 31 Participants |
| Long, Long, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 23 Participants |
| Short, Short, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 21 Participants |
| Short, Long, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 27 Participants |
| Long, Short, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 29 Participants |
| Long, Long, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 22 Participants |
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short, Short, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 21 Participants |
| Short, Long, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 23 Participants |
| Long, Short, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 23 Participants |
| Long, Long, Present | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 26 Participants |
| Short, Short, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 19 Participants |
| Short, Long, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 21 Participants |
| Long, Short, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 26 Participants |
| Long, Long, Absent | Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half | 23 Participants |
Secondary
Proportion of Patients Who Make an Intentional Attempt to Quit Smoking
Intentional attempt to quit smoking cigarettes that lasts for \>=24 hours
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Short, Short, Present | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 37 Participants |
| Short, Long, Present | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 40 Participants |
| Long, Short, Present | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 33 Participants |
| Long, Long, Present | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 44 Participants |
| Short, Short, Absent | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 36 Participants |
| Short, Long, Absent | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 38 Participants |
| Long, Short, Absent | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 35 Participants |
| Long, Long, Absent | Proportion of Patients Who Make an Intentional Attempt to Quit Smoking | 29 Participants |