Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking

Cigarette Smoker Clinical Trial

Official title:

Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669120
• Other study ID #: 2016-0564
• Secondary ID: NCI-2018-0182120
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: March 25, 2020

Study information

• Verified date: April 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.

Description:

PRIMARY OBJECTIVES:

I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus [vs.] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.

SECONDARY OBJECTIVES:

I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.

EXPLORATORY OBJECTIVES:

I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.

ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.

After completion of study, participants are followed up at 3 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female owning a cell phone with a reachable contact number

• Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status

• Smoked at least 100 cigarettes in lifetime

• Currently smoking at least 5 cigarettes a day, on average

• Willing to set a quit smoking date within a week of the enrollment

• English speaking

Exclusion Criteria:

• Expired carbon monoxide (CO) levels below 7 ppm

• Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)

• Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)

• Pregnant or nursing

• Enrolled in another smoking cessation program

• Partner enrolled on current study

Related Conditions & MeSH terms

• Cigarette Smoker
• Current Every Day Smoker

Intervention

Other:
• Informational Intervention
Receive advice to quit smoking and materials to promote smoking cessation

Behavioral:
• Telephone-Based Intervention
Receive individualized text based messages

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Point prevalence abstinence	Seven day smoking abstinence along with negative saliva cotinine will be the primary definition of smoking abstinence for this study. Important covariates that will be used to adjust for potential baseline differences include level of education, biological sex, marital status, gender identity, race, working status, income, years smoking, smoking initiation, use of other tobacco products, and living with other household members who smoke.	Up to 6 months
Other	Salivary cotinine assessed by NicAlert test	Important covariates that will be used to adjust for potential baseline differences include level of education, biological sex, marital status, gender identity, race, working status, income, years smoking, smoking initiation, use of other tobacco products, and living with other household members who smoke.	Up to 6 months
Primary	Computing recruitment rate	Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.	At baseline
Primary	Retention rates	Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.	At 3 and 6 months
Secondary	Levels of helpfulness	Will be measured by asking: "Were the text messages helpful in your attempt to quit smoking cigarettes?" (Likert scale from 0= Not at all helpful to 4=Very helpful). Will use t-test to compare between arms.	Up to 6 months
Secondary	Appropriateness	Will be measured by asking: "Regarding the number of text messages received per day, did you think that there were:" (Likert scale from 0=Too many to 2=Not enough). Will use t-test to compare between arms.	Up to 6 months
Secondary	Perceived difficulty	Will be measured by asking: "How easy was it to view the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy) "How easy was it to respond to the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy). Will use t-test to compare between arms.	Up to 6 months

External Links

•   MD Anderson Cancer Center Website