A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking

Study Overview
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Brief Summary
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This clinical trial compares a new smoking cessation smartphone application (app) (iCanQuit) to an existing smarphone app (National Cancer Institute [NCI] QuitGuide) for helping American Indians and Alaska Natives (AIANs) quit smoking. Compared to other racial/ethnic groups, AIANs have 6 times higher rates of developing smoking-related cancers, including lung cancer. Commercial cigarette smoking accounts for half of all deaths among AIANs nationwide. AIANs' often lack of access to smoking cessation interventions, which may be due to inequities in the healthcare system, lack of health insurance, living in rural areas, systemic racism, and historical trauma. There is also a lack of effective smoking cessation interventions for AIANs. Smartphone apps have the potential to deliver a low-cost smoking cessation intervention with wide reach to AIANs. Apps require no in-person delivery and no provider training, do not require integration into complex hospital systems, can be freely accessed on an app store, and are available at any time and any place. iCanQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges, staying motivated, and preventing relapse. The iCanQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking.

Detailed Description
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OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use the iCanQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors on study. ARM II: Participants use the NCI QuitGuide app on study. After completion of study intervention, patients are followed up at 3, 6, and 12-months.

Official Title
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Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Behavioral: Smoking Cessation Intervention
* Behavioral: Smoking Cessation Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as American Indian or Alaska Native, either alone or in combination with other races Age 18 and older Has smoked daily for the past year Interest in quitting smoking within the next 30 days Willing to be randomly assigned to either app Have daily access to their own Android or iPhone Able to download a smartphone app Be willing and able to read English Not currently or within past 30 days using other smoking cessation behavioral interventions or smoking cessation pharmacotherapies Have never participated in our prior research Have no other household or family member participating Being willing to complete the 3, 6, and 12-month follow-up assessments Providing email, phone number(s), and mailing address Living off United States (US) AIAN tribal reservations or living on five Northern Plains tribal reservations from whom we would obtain approvals to recruit Exclusion Criteria: Currently (i.e., within past 30 days) using other smoking cessation behavioral interventions or pharmacotherapy to aid cessation Has participated in our prior research trials Has used the National Cancer Institute's (NCI's) QuitGuide app Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization Not providing email, phone number(s), and mailing address

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (iCanQuit app)<br>Participants use the iCanQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors on study. | Procedure: Biospecimen Collection<br>* Ancillary studies<br>* Other names: Specimen Collection;Behavioral: Smoking Cessation Intervention<br>* Use iCanQuit smartphone app<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (NCI QuitGuide app)<br>Participants use the NCI QuitGuide app on study. | Procedure: Biospecimen Collection<br>* Ancillary studies<br>* Other names: Specimen Collection;Behavioral: Smoking Cessation Intervention<br>* Use NCI QuitGuide smartphone app<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day point prevalence abstinence (PPA) | Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model. | At 12 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day PPA | Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model. | At 3- and 6-months post randomization | 
| Self-reported 24-hour PPA | A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model. | At the 3, 6, and 12-month follow-ups | 
| Self-reported 7-day PPA | A secondary definition of cessation will include self-reported abstinence from cigarettes and all other commercial nicotine-containing tobacco products (i.e., e-cigarettes or vaping, chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, kreteks). Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model. | At the 3, 6, and 12-month follow-ups |