Smoking Cessation
Conditions
Keywords
lesbian, gay, bisexual, transgender, queer (LGBTQ)
Brief summary
The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program
Interventions
BEHAVIORALSmokefreeSGM
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
BEHAVIORALSmokefreeTXT
Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
Sponsors
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identify as an LGBTQ+ individual * Currently live in the United States * Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke greater than or equal to 5 cigarettes a day * Are willing to quit smoking in the next 15 days * Have a cell phone number with an unlimited short message service (SMS) plan * Have a positive cotinine saliva test to indicate their smoking status
Exclusion criteria
* Have a prepaid cell phone plan (pay-as-you-go plan) * Have a cell phone number that does not work and/or is registered to someone else * Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person * Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development) * Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study. * Current use of tobacco cessation medications * Enrollment in another smoking cessation study * Non-English speakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as Assessed by Number of Participants Recruited for the Study | Baseline |
| Feasibility as Assessed by Number of Participants That Completed Month 1 Visit | end of month 1 |
| Feasibility as Assessed by Number of Participants That Completed Month 3 Visit | end of month 3 |
| Feasibility as Assessed by Number of Participants That Completed Month 6 Visit | end of month 6 |
| Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews | 6 months follow up |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants That Quit Smoking | 1 month follow up |
Countries
United States
Participant flow
Pre-assignment details
Of the 217 participants screened, 100 participants met all inclusion criteria, were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| SmokefreeTXT SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population | 50 |
| SmokefreeSGM SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | SmokefreeTXT | SmokefreeSGM | Total |
|---|---|---|---|
| Age at smoking initation | 15.3 years STANDARD_DEVIATION 2.7 | 14.3 years STANDARD_DEVIATION 3.3 | 14.8 years STANDARD_DEVIATION 3.1 |
| Age, Continuous | 41.6 years STANDARD_DEVIATION 12.7 | 38.2 years STANDARD_DEVIATION 12.2 | 41.1 years STANDARD_DEVIATION 12.1 |
| Children in household No | 38 Participants | 38 Participants | 76 Participants |
| Children in household Yes | 12 Participants | 12 Participants | 24 Participants |
| E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index high dependence | 8 Participants | 4 Participants | 12 Participants |
| E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index Low dependence | 6 Participants | 3 Participants | 9 Participants |
| E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index medium dependence | 5 Participants | 2 Participants | 7 Participants |
| E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index Not Dependent | 8 Participants | 4 Participants | 12 Participants |
| Level of Education Bachelor's/ master's /associate degree | 13 Participants | 18 Participants | 31 Participants |
| Level of Education less than or equal to High school | 9 Participants | 13 Participants | 22 Participants |
| Level of Education Technical/vocational degree/ Completed some college | 28 Participants | 19 Participants | 47 Participants |
| Marital Status Married/Living with significant other | 14 Participants | 14 Participants | 28 Participants |
| Marital Status Single/Separate/Divorced/Widowed | 36 Participants | 36 Participants | 72 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence mild dependance on nicotine | 11 Participants | 11 Participants | 22 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence moderate dependance on nicotine | 33 Participants | 22 Participants | 55 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence severe dependance on nicotine | 6 Participants | 17 Participants | 23 Participants |
| Number of Participants who live with other smokers | 19 Participants | 16 Participants | 35 Participants |
| Number of participants who smoke electronic cigarettes | 27 Participants | 13 Participants | 40 Participants |
| Number of times participants tried to quit smoking Between 1 and 10 times | 35 Participants | 38 Participants | 73 Participants |
| Number of times participants tried to quit smoking More than 10 times | 13 Participants | 8 Participants | 21 Participants |
| Number of times participants tried to quit smoking Never tried | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 29 Participants | 31 Participants | 60 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 0 Participants | 5 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 57 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 43 Participants |
| Sexual Orientation Gay Male/Bisexual Male | 20 Participants | 17 Participants | 37 Participants |
| Sexual Orientation Lesbian/Gay Woman/ Bisexual Female | 24 Participants | 26 Participants | 50 Participants |
| Sexual Orientation Others (pansexual, queer, unsure) | 6 Participants | 7 Participants | 13 Participants |
| Work Status Not Working | 21 Participants | 22 Participants | 43 Participants |
| Work Status Working | 29 Participants | 28 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews
Time frame: 6 months follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews | 16 Participants |
| SmokefreeTXT | Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews | 9 Participants |
Primary
Feasibility as Assessed by Number of Participants Recruited for the Study
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Feasibility as Assessed by Number of Participants Recruited for the Study | 100 Participants |
Primary
Feasibility as Assessed by Number of Participants That Completed Month 1 Visit
Time frame: end of month 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Feasibility as Assessed by Number of Participants That Completed Month 1 Visit | 35 Participants |
| SmokefreeTXT | Feasibility as Assessed by Number of Participants That Completed Month 1 Visit | 34 Participants |
Primary
Feasibility as Assessed by Number of Participants That Completed Month 3 Visit
Time frame: end of month 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Feasibility as Assessed by Number of Participants That Completed Month 3 Visit | 22 Participants |
| SmokefreeTXT | Feasibility as Assessed by Number of Participants That Completed Month 3 Visit | 20 Participants |
Primary
Feasibility as Assessed by Number of Participants That Completed Month 6 Visit
Time frame: end of month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Feasibility as Assessed by Number of Participants That Completed Month 6 Visit | 19 Participants |
| SmokefreeTXT | Feasibility as Assessed by Number of Participants That Completed Month 6 Visit | 16 Participants |
Secondary
Number of Participants That Quit Smoking
Time frame: 1 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Number of Participants That Quit Smoking | 18 Participants |
| SmokefreeTXT | Number of Participants That Quit Smoking | 15 Participants |
Secondary
Number of Participants That Quit Smoking
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Number of Participants That Quit Smoking | 7 Participants |
| SmokefreeTXT | Number of Participants That Quit Smoking | 8 Participants |
Secondary
Number of Participants That Quit Smoking
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants Screened | Number of Participants That Quit Smoking | 3 Participants |
| SmokefreeTXT | Number of Participants That Quit Smoking | 7 Participants |