Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

Smokeless Tobacco Cessation Clinical Trial

Official title:

Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613689
• Other study ID #: Pro00063791
• Secondary ID: 1R15CA198841-01
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS) text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural population.

Description:

Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks.

Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

• Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week

• Have an address in a rural census tract defined by a RUCA code of 4-10.

• Interested in participating in a cessation program

• Have access to a cell phone with unlimited texting ability and have knowledge of text messaging

Exclusion Criteria:

• Non-English speaking

• Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user)

• Currently participating in a smokeless tobacco cessation study

• Family member participating in a smokeless tobacco cessation study

Related Conditions & MeSH terms

• Smokeless Tobacco Cessation

Intervention

Behavioral:
• Scheduled Gradual Reduction (SGR)
Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use. In addition, this group will also receive the support messages that are sent to the control group.
• Text Messages
Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.

Locations

Country	Name	City	State
United States	Duke University School of Nursing	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Return Text Messages sent in Response to SGR Intervention	Assessed via text history	1 month
Primary	Proportion of Support Messages Read by Participants	Self-report	1 month
Primary	Ratings of Usefulness of the Intervention Received	Ratings will be assessed via patient questionnaire.	1 month
Primary	Quit Rate at 1 month	Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.	1 month
Primary	Quit Rate at 6 Months	Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco.	6 months