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

NCT03669120 | Completed

• 3 other identifiers: 2016-0564NCI-2018-01821P30CA016672
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoker; Current Every Day Smoker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Levels of helpfulness

  Up to 6 months

• Appropriateness

  Up to 6 months

• Perceived difficulty

  Up to 6 months

Other Outcomes (2)

• Point prevalence abstinence

  Up to 6 months

• Salivary cotinine assessed by NicAlert test

  Up to 6 months

Study Arms (2)

Arm I (mainstream instructional care)

ACTIVE COMPARATOR

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

Arm II (tailored intensive care)

EXPERIMENTAL

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; Behavioral: Telephone-Based Intervention

Interventions

Informational Intervention OTHER

Receive advice to quit smoking and materials to promote smoking cessation

Arm I (mainstream instructional care); Arm II (tailored intensive care)

Telephone-Based Intervention BEHAVIORAL

Receive individualized text based messages

Arm II (tailored intensive care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Irene Tami-Maury

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: August 10, 2018
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Locations

US (1)