Smokeless Tobacco Cessation Intervention for Firefighters

Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters

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.

Study Overview

• Status: Completed
• Conditions: Smokeless Tobacco Cessation
• Intervention / Treatment: Behavioral: #EnufSnuff.TXT- First Responder; Behavioral: Enough Snuff Intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: #EnufSnuff.TXT- First Responder; Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention	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.
Active Comparator: Enough Snuff Intervention; Participants in this group will receive tobacco cessation materials	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of First Responders Recruited Who Completed a Screening Assessment		Within 3 months of the initiation of study recruitment
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
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.	30 days following the end of the 10-week intervention
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).	30 days following the end of the 10-week intervention
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).	30 days following the end of the 10-week intervention
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).	30 days following the end of the 10-week intervention
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).	30 days following the end of the 10-week intervention
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?"	30 days following the end of the 10-week intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Devon Noonan, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Firefighters; Smokeless Tobacco; Quitting Smokeless Tobacco; First Responders
• Other Study ID Numbers: Pro00109404; 5R01CA242593-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No