Smokeless Tobacco Cessation
Conditions
Keywords
Firefighters, Smokeless Tobacco, Quitting Smokeless Tobacco, First Responders
Brief summary
The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups. The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders. The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.
Interventions
BEHAVIORAL#EnufSnuff.TXT- First Responder
Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco.
BEHAVIORALEnough Snuff Intervention
Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges.
Sponsors
National Cancer Institute (NCI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Professional firefighters or first responders * 18 years or older * Have used smokeless tobacco for the past year and current (past 30 days) smokeless tobacco daily use * Access to a smartphone
Exclusion criteria
* Not a professional firefighter or first responder * Under 18 years of age * Have not used smokeless tobacco for the past year and are not current (past 30 days) smokeless tobacco daily use * No access to a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm | Within 3 months of the initiation of study recruitment | — |
| Number of First Responders Recruited Who Completed a Screening Assessment | Within 3 months of the initiation of study recruitment | — |
| Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire | 30 days following the end of the 10-week intervention | Study engagement defined as completing the End of Intervention Program assessment. |
| Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire | 30 days following the end of the 10-week intervention | Usefulness was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful). |
| Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire | 30 days following the end of the 10-week intervention | Helpfulness was measured on a scale of 1-5 where 1=not at all, 2=somewhat, 3=Undecided, 4=very, 5=extremely. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) and 1=yes (very, extremely). |
| Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire | 30 days following the end of the 10-week intervention | Considered quitting was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful). |
| Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire | 30 days following the end of the 10-week intervention | Recommend to friend was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were then dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful). |
| Number of Participants Who Quit Smokeless Tobacco Measured by Self Report | 30 days following the end of the 10-week intervention | Quit was determined by the self-report response (yes or no) to the question, In the past 7 days, have you used any dip? |
Countries
United States
Participant flow
Recruitment details
All participants were recruited using social media (i.e., Facebook). An advertising profile for the study targeted the study population (e.g., current smokeless tobacco users (chewer/dipper), at or over age 18, currently working or volunteering as a firefighter or first responder, with access to a smartphone). This was a single-site study, which used electronic consents and survey measures.
Pre-assignment details
Participants were required to verify their age, location, and smokeless tobacco use when submitting their information via the advertisement. During the electronic screener survey, participants were required to verify their age, first responder status, and use of smokeless tobacco as well. If any answers were outside of the eligibility requirements, they were directed to an ineligibility notification screen in the RedCap system. Those deemed eligible proceeded to the Baseline survey.
Participants by arm
| Arm | Count |
|---|---|
| #EnufSnuff.TXT- First Responder Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention and support text messages.
#EnufSnuff.TXT- First Responder: Participants in this intervention will be given the choice of following the Gradual Reduction to Quit program or to choose their own quit date within 2-4 weeks. The Gradual Reduction to Quit program will reduce smokeless tobacco use via text message support and weekly prompts guiding the participants to gradually decrease their use of smokeless tobacco until they are down to zero. A four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges will also be provided to all participants. The intent of this program is to reduce the number of times participants use smokeless tobacco. | 30 |
| Enough Snuff Intervention Participants in this group will receive tobacco cessation materials and support text messages.
Enough Snuff Intervention: Participants will be sent the Enuf Snuff cessation manual, support text messages, as well as a four week Nicotine Replacement Therapy (NRT) sample in the form of lozenges. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | #EnufSnuff.TXT- First Responder | Total | Enough Snuff Intervention |
|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 9.6 | 37.5 years STANDARD_DEVIATION 9.9 | 37.7 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 59 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 57 Participants | 29 Participants |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 29 Participants | 59 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm
Time frame: Within 3 months of the initiation of study recruitment
Population: First responders who met the study eligibility criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm | 30 Participants |
| Enough Snuff Intervention | First Responders Who Met the Study Eligibility Criteria, Were Enrolled, and Randomized to a Treatment Arm | 30 Participants |
Primary
Number of First Responders Recruited Who Completed a Screening Assessment
Time frame: Within 3 months of the initiation of study recruitment
Population: First responders recruited and screened for the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of First Responders Recruited Who Completed a Screening Assessment | 163 Participants |
Primary
Number of Participants Who Quit Smokeless Tobacco Measured by Self Report
Quit was determined by the self-report response (yes or no) to the question, In the past 7 days, have you used any dip?
Time frame: 30 days following the end of the 10-week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of Participants Who Quit Smokeless Tobacco Measured by Self Report | 12 Participants |
| Enough Snuff Intervention | Number of Participants Who Quit Smokeless Tobacco Measured by Self Report | 10 Participants |
p-value: 0.592595% CI: [0.465, 3.823]Regression, Logistic
Primary
Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire
Considered quitting was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Time frame: 30 days following the end of the 10-week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire | 16 Participants |
| Enough Snuff Intervention | Number of Participants Who Stated Intervention Made Them Consider Quitting as Measured by Questionnaire | 14 Participants |
p-value: 0.605895% CI: [0.474, 3.602]Regression, Logistic
Primary
Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire
Usefulness was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Time frame: 30 days following the end of the 10-week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire | 5 Participants |
| Enough Snuff Intervention | Number of Participants Who Stated Intervention Was Useful as Measured by Questionnaire | 6 Participants |
p-value: 0.738995% CI: [0.215, 2.972]Regression, Logistic
Primary
Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire
Helpfulness was measured on a scale of 1-5 where 1=not at all, 2=somewhat, 3=Undecided, 4=very, 5=extremely. Ratings were dichotomized for the analysis as 0=no (not at all, somewhat, undecided) and 1=yes (very, extremely).
Time frame: 30 days following the end of the 10-week intervention
Population: Not relevant to the Enough Snuff Intervention arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of Participants Who Stated That #EnufSnuff.TXT Intervention Was Helpful as Measured by Questionnaire | 9 Participants |
Primary
Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire
Recommend to friend was measured on a scale of 1-5, where 1=Not at all useful, 2=Somewhat useful, 3=Undecided, 4=Very useful, 5=Extremely useful. Ratings were then dichotomized for the analysis as 0=no (not at all, somewhat, undecided) or 1=yes (very, extremely useful).
Time frame: 30 days following the end of the 10-week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire | 11 Participants |
| Enough Snuff Intervention | Number of Participants Who Stated They Would Recommend Program to a Friend as Measured by Questionnaire | 11 Participants |
95% CI: [0.349, 2.866]
Primary
Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire
Study engagement defined as completing the End of Intervention Program assessment.
Time frame: 30 days following the end of the 10-week intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recruited First Responders | Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire | 23 Participants |
| Enough Snuff Intervention | Percent of Participants Engaged With the Program as Measured by Completion of the End of Program Questionnaire | 23 Participants |
p-value: 195% CI: [0.302, 3.309]Regression, Logistic