Clinical trial NCT03669120: Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking
Official title: Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoker
Current Every Day Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-13
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Computing recruitment rate
timeFrame: At baseline
measure: Retention rates
timeFrame: At 3 and 6 months
Secondary outcomes:
measure: Levels of helpfulness
timeFrame: Up to 6 months
measure: Appropriateness
timeFrame: Up to 6 months
measure: Perceived difficulty
timeFrame: Up to 6 months
Other outcomes:
measure: Point prevalence abstinence
timeFrame: Up to 6 months
measure: Salivary cotinine assessed by NicAlert test
timeFrame: Up to 6 months
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Irene Tami-Maury
role: PRINCIPAL_INVESTIGATOR
References: