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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-08892 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U19MD020533 | U.S. NIH Grant/Contract | View source | |
| FHIRB0020651 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.
OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.
ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (QuitBot chatbot) | Experimental | Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study. |
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| Arm II (QuitBot texting) | Active Comparator | Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuitBot Smoking Cessation Chatbot Program | Device | Participate in Quitbot chatbot program |
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| Measure | Description | Time Frame |
|---|---|---|
| 30-day point prevalence abstinence (PPA) | Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months. | At 12-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day PPA | Also 24-hour and 7-day PPA at the 3-, 6-, and 12- month follow-ups. Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) CO-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Bricker, PhD | Contact | 206-667-5074 | jbricker@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bricker, PhD | 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 |
The trial results data will be published on ClinicalTrials.gov. The de-identified scientific data will be made available as public use data to the research community in openICPSR. No PII or PHI data will be shared or available for secondary use.
The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads.
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Random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by survey research unit that will be blind to random assignment.
| QuitBot Smoking Cessation Text Messaging Program | Device | Participate in Quitbot texting program |
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| Survey Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| Carbon Monoxide Measurement | Procedure | Ancillary studies |
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| At 3- and 6- months post-randomization |
| Measures of bond between user and conversational chatbot | Will be measured via four subscales of the 12-item Working Alliance Inventory for Tobacco (WAIT-12), with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. Number of times participants engaged with the intervention will be adjusted in Poisson regressions that account for the number of prompts a participant received. | At 3- and 6-months post-randomization |
| Agreement on goals of treatment | Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. | At 3- and 6-months post-randomization |
| Agreement on tasks of treatment | Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. | At 3- and 6-months post-randomization |
| User's sense that QuitBot understands their needs | Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. | At 3- and 6-months post-randomization |
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D002248 | Carbon Monoxide |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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