Smoking Cessation
Conditions
Keywords
LGBTQI
Brief summary
The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.
Interventions
BEHAVIORALSmokefreeSGM
Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
Sponsors
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their lifetime and smokes everyday * Have an interest in quitting smoking in the next 15 days * Have a cellphone number with an unlimited short messaging service (SMS) plan * Have US mailing and email addresses * Positive cotinine saliva test results
Exclusion criteria
* Individuals who are found to have a prepaid cell phone * Individuals who are found to have a cellphone number that does not work or is registered to someone else * Pregnant or breastfeeding women * Contraindication for nicotine patch * Regular use of tobacco products other than cigarettes * Current use of tobacco cessation medications * Enrolled in another smoking cessation study * Non-English speakers * Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Usability as Assessed by the System Usability Scale (SUS) | 1 month after quit date | The 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | 1 month after enrollment | A participant's engagement rate was determined by dividing the total number of participant responses to the bidirectional text messages (numerator) by the total number of bidirectional text messages sent by the text-based platform (denominator). Participants who had rates ≤33.3% were classified as having low engagement, 33.3-66.6% moderate engagement, and ≥66.7% high engagement. Data are reported categorically as number of participants who have low, moderate, or high engagement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Beta Testing Group SmokefreeSGM: Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Beta Testing Group |
|---|---|
| Age at which participant first smoked | 14.8 years STANDARD_DEVIATION 2.96 |
| Age, Continuous | 39 years STANDARD_DEVIATION 12.16 |
| Children in household No | 15 Participants |
| Children in household Yes | 3 Participants |
| Education College or higher | 5 Participants |
| Education Some college or less | 13 Participants |
| Level of Smoking Heavy smoker (>10 cigarettes per day) | 7 Participants |
| Level of Smoking Light smoker (less than or equal to 10 cigarettes per day) | 11 Participants |
| Marital status married/living with significant other | 1 Participants |
| Marital status Single/separated/divorced/widowed | 17 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence high dependence on nicotine | 5 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence low dependence | 6 Participants |
| Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence moderate dependence | 7 Participants |
| Number of Participants who live with other smokers | 2 Participants |
| Number of times participants tried to quit smoking Between 1 and 5 times | 9 Participants |
| Number of times participants tried to quit smoking More than 5 times | 8 Participants |
| Number of times participants tried to quit smoking Never | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 9 Participants |
| Sex/Gender, Customized Female | 7 Participants |
| Sex/Gender, Customized Male | 7 Participants |
| Sex/Gender, Customized Nonbinary, genderfluid, or genderqueer | 4 Participants |
| Sexual Orientation Bisexual female | 5 Participants |
| Sexual Orientation Bisexual Male | 3 Participants |
| Sexual Orientation Gay man/Men who have sex with men | 5 Participants |
| Sexual Orientation Lesbian/gay woman/Women who have sex with women | 2 Participants |
| Sexual Orientation Other | 3 Participants |
| Work Status Not working | 1 Participants |
| Work Status Working full time | 13 Participants |
| Work Status Working part-time | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Perceived Usability as Assessed by the System Usability Scale (SUS)
The 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable.
Time frame: 1 month after quit date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Beta Testing Group | Perceived Usability as Assessed by the System Usability Scale (SUS) | 81.67 score on a scale | Standard Deviation 15.46 |
Secondary
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
A participant's engagement rate was determined by dividing the total number of participant responses to the bidirectional text messages (numerator) by the total number of bidirectional text messages sent by the text-based platform (denominator). Participants who had rates ≤33.3% were classified as having low engagement, 33.3-66.6% moderate engagement, and ≥66.7% high engagement. Data are reported categorically as number of participants who have low, moderate, or high engagement.
Time frame: 1 month after enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Beta Testing Group | Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | Low engagement | 5 Participants |
| Beta Testing Group | Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | moderate engagement | 3 Participants |
| Beta Testing Group | Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment. | high engagement | 10 Participants |