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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-02453 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| FHIRB0020404 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| U54CA132381 | U.S. NIH Grant/Contract | View source |
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Study never opened to accrual and will not proceed due to lack of funding.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Cancer Institute Center to Reduce Cancer Health Disparities | UNKNOWN |
| New Mexico State University | OTHER |
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This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking.
OUTLINE:
Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program A) that helps explore personal values and teaches participants about smoking triggers and skills to help them manage cravings and accept thoughts and feelings related to smoking. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.
GROUP II: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program B) that is based on current clinical practice guidelines for tobacco cessation to help them quit smoking. This program helps with quit advice, tracking progress on quitting smoking, and managing cravings. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.
After completion of study intervention, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (EQQUAL-NM, Program A) | Experimental | Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program A) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. |
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| Arm II (EQQUAL-NM, Program B) | Active Comparator | Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program B) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone App-delivered Smoking Cessation Intervention | Behavioral | Receive access to EQQUAL-NM (Program A) intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant satisfaction | Self-report of satisfaction overall and with specific program components will be rated on a 5-point Likert-type scale. Higher scale scores indicate higher satisfaction with the app. | At 3-month follow-up |
| Number of logins to the assigned application | Server-recorded number of app openings over 3 months | Up to 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products | Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications | At 3 months |
| Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products |
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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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Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked.
| Smartphone App-delivered Smoking Cessation Intervention | Behavioral | Receive access to EQQUAL-NM (Program B) intervention |
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| Health Promotion and Education | Other | Receive text message reminders, motivational messages and prompts via SMS text messages (Program A) |
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| Health Promotion and Education | Other | Receive text message reminders, motivational messages and prompts via SMS text messages (Program B) |
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| Biospecimen Collection | Other | Complete at-home saliva sample collection |
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| Questionnaire Administration | Other | Ancillary studies |
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Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine |
| At 3 months |
| Self-reported 30-day PPA from all nicotine/tobacco products | Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications | At 3 months |
| Biochemically confirmed 30-day PPA from all nicotine/tobacco products | Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine | At 3 months |
| Self-reported 7-day PPA from cigarette smoking | Self-report of no cigarette smoking over the previous 7 days | At 3 months |
| Self-reported 30-day PPA from cigarette smoking | Self-report of no cigarette smoking over the previous 30 days | At 3 months |
| Change in Contemplation Ladder scores | Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Ladder scores are on a 0 to 10 scale, with higher change scores meaning greater increases readiness to quit. | At baseline and at 3-month follow-up |
| Change in acceptance of tobacco-use triggers | Change in acceptance of tobacco-use triggers will be measured using the Avoidance and Inflexibility Scale. Higher change scores indicate greater improvement in acceptance of tobacco use triggers. | At baseline and at 3-month follow-up |
| Change in values-guided action | Change in values-guided action measured using the Values Questionnaire. Higher change scores indicate greater improvement in values-guided action. | At baseline and at 3-month follow-up |
| 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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