Smokeless Tobacco Cessation Intervention for Firefighters

Study Overview
=================
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.

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

Conditions
-----------------
Smokeless Tobacco Cessation

Intervention / Treatment
-----------------
* Behavioral: Gradual Reduction to Quit
* Behavioral: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smokeless Tobacco Reduction Group<br>Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention | Behavioral: Gradual Reduction to Quit<br>* 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.<br>|
| Active Comparator: Control Group<br>Participants in this group will receive tobacco cessation materials | Behavioral: Control Group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants recruited as measured by enrollment log |  | Up to 3 months | 
| Percent of participants enrolled as measured by enrollment log |  | Up to 3 months | 
| Percent of participants who are still engaged with the program after 30 days |  | Up to 30 days | 
| Percent of firefighters who stated intervention was useful as measured by questionnaire |  | Up to 12 weeks | 
| Percent of firefighters who stated intervention changed smokeless tobacco use as measured by questionnaire |  | Up to 12 weeks | 
| Percent of firefighters who stated intervention made them think about quitting as measured by questionnaire |  | Up to 12 weeks | 
| Percent of firefighters who stated they would recommend program to a friend as measured by questionnaire |  | Up to 12 weeks | 
| Percent of participants who quit smokeless tobacco measured by self report |  | Up to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Firefighters, Smokeless Tobacco, Quitting Smokeless Tobacco, First Responders