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OpenTrials
Completed

NCT Number: NCT03669120

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

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.

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Key information

Conditions

Cigarette Smoker Current Every Day Smoker

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Receive advice to quit smoking and materials to promote smoking cessation

Telephone-Based Intervention

Behavioral

Receive individualized text based messages

Primary outcomes

  1. Computing recruitment rate

    Time frame: At baseline

    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.

  2. Retention rates

    Time frame: At 3 and 6 months

    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.

Secondary outcomes

  1. Levels of helpfulness

    Time frame: Up to 6 months

    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.

  2. Appropriateness

    Time frame: Up to 6 months

    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.

  3. Perceived difficulty

    Time frame: Up to 6 months

    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.

Other outcomes

  1. Point prevalence abstinence

    Time frame: Up to 6 months

    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.

  2. Salivary cotinine assessed by NicAlert test

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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