Smokeless Tobacco Cessation Intervention for Firefighters

Sponsor
Duke University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05111041
Collaborator
National Cancer Institute (NCI) (NIH)
70
1
2
7.2
9.8

Study Details

Study Description

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. The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters who wish to stop using smokeless tobacco.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Scheduled Gradual Reduction
  • Behavioral: Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters
Actual Study Start Date :
Jan 25, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Smokeless Tobacco Reduction Group

Participants in this group will receive a mobile gradual smokeless tobacco reduction intervention

Behavioral: Scheduled Gradual Reduction
The SGR program will reduce smokeless tobacco use. The intent of this program is to reduce the number of times participants use smokeless tobacco.

Active Comparator: Control

Participants in this group will receive tobacco cessation materials

Behavioral: Control
Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team.

Outcome Measures

Primary Outcome Measures

  1. Percent of participants recruited as measured by enrollment log [Up to 3 months]

  2. Percent of participants enrolled as measured by enrollment log [Up to 3 months]

  3. Percent of participants who are still engaged with the program after 30 days [Up to 30 days]

  4. Percent of firefighters who stated intervention was useful as measured by questionnaire [Up to 12 weeks]

  5. Percent of firefighters who stated intervention changed smokeless tobacco use as measured by questionnaire [Up to 12 weeks]

  6. Percent of firefighters who stated intervention made them think about quitting as measured by questionnaire [Up to 12 weeks]

  7. Percent of firefighters who stated they would recommend program to a friend as measured by questionnaire [Up to 12 weeks]

  8. Percent of participants who quit smokeless tobacco measured by self report [Up to 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Professional firefighters

  • 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Devon Noonan, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05111041
Other Study ID Numbers:
  • Pro00109404
  • 5R01CA242593-03
First Posted:
Nov 8, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University

Study Results

No Results Posted as of Apr 4, 2022