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

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

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.

Study Overview

• Status: Completed
• Conditions: Current Every Day Smoker; Cigarette Smoker
• Intervention / Treatment: Other: Informational Intervention; Behavioral: Telephone-Based Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (mainstream instructional care); Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation.	Other: Informational Intervention; Receive advice to quit smoking and materials to promote smoking cessation
Experimental: Arm II (tailored intensive care); 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.	Other: Informational Intervention; Receive advice to quit smoking and materials to promote smoking cessation; Behavioral: Telephone-Based Intervention; Receive individualized text based messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Irene Tami-Maury, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0564 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-01821 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

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