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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01821 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-0564 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive advice to quit smoking and materials to promote smoking cessation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of helpfulness | 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. | Up to 6 months |
| Appropriateness |
| Measure | Description | Time Frame |
|---|---|---|
| Point prevalence abstinence | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Tami-Maury | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Telephone-Based Intervention | Behavioral | Receive individualized text based messages |
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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. |
| Up to 6 months |
| Perceived difficulty | 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. | Up to 6 months |
| Up to 6 months |
| Salivary cotinine assessed by NicAlert test | 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. | Up to 6 months |