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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03050 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1123270 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| The Leonard and Norma Klorfine Foundation | UNKNOWN |
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This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.
ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (EQQUAL A) | Experimental | Participants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages. |
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| Arm II (EQQUAL B) | Active Comparator | Participants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Smoking Cessation Intervention | Behavioral | Receive EQQUAL A intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall satisfaction | Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of "mostly satisfied" or "very satisfied" versus all other responses (i.e., "not at all," "a little," and "somewhat"). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | At 3-month follow-up |
| Average change in Contemplation Ladder scores | Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | Baseline through 3-month follow-up |
| Reduction in cigarettes smoked per day | Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). | Baseline through 3-month follow-up |
| 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use | Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the acceptance of smoking triggers | Assessed by the emotional and physical subscales of the Avoidance and Inflexibility Scale (AIS). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2023 | Mar 7, 2024 |
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| Online Smoking Cessation Intervention | Behavioral | Receive EQQUAL B intervention |
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| Questionnaire Administration | Other | Ancillary studies |
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| Health Promotion and Education | Other | Receive motivational messages and smoking cessation information via SMS text messages |
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| At 3-month follow-up |
| Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program | Measured by the System Usability Scale. Will be presented descriptively as an average usability score. | At 3-month follow-up |
| Acceptability of the EQQUAL avatar | Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages. | At 3-month follow-up |
| Number of EQQUAL sessions completed | Will be presented descriptively as frequencies and percentages. | Up to 3 months |
| Baseline through 3-month follow-up |
| Changes in psychological flexibility | Assessed by the short version of the Multidimensional Psychological Flexibility Inventory (MPFI). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. | Baseline through 3-month follow-up |
| Changes in valued living | Assessed by the Valuing Questionnaire. Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome. | Baseline through 3-month follow-up |
| Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit | Will be presented descriptively as frequencies and percentages. | Baseline through 3-month follow-up |
| Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't | Will be presented descriptively as frequencies and percentages. | Baseline through 3-month follow-up |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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