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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08031 | Registry Identifier | NCI / CTRP | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| 10396 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Safeway Foundation | UNKNOWN |
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This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.
OUTLINE:
Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Participants are followed up with at 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (Flexiquit+, text message, handout) | Experimental | Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Smoking Cessation Intervention | Behavioral | Use the Flexiquit+ program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment utilization | Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided. | Enrollment up to 2 months |
| Treatment satisfaction: survey | Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided. | Enrollment up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation rate | Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine. | At 2 months post-enrollment |
| Change in motivation to quit smoking |
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Inclusion 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 | May 7, 2020 | Jul 9, 2020 |
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| Text Message | Other | Receive text messages |
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| Handout | Other | Receive handouts via email |
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| Questionnaire Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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Will be assessed using the Contemplation Ladder.
| From baseline to 2-month follow-up |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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