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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Cigarette Smoker; Current Every Day Smoker

Treatments: Other: Informational Intervention; Behavioral: Telephone-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03669120

P30CA016672 (U.S. NIH Grant/Contract)

2016-0564 (Other Identifier)

NCI-2018-01821 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Arm I (mainstream instructional care)

Active Comparator group

Description:

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.

Treatment:

Other: Informational Intervention

Arm II (tailored intensive care)

Experimental group

Description:

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.

Treatment:

Other: Informational Intervention

Behavioral: Telephone-Based Intervention