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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2028-11-30

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.

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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 for at least 45 days on study.

ARM II: Participants use the NCI QuitGuide app for at least 45 days on study.

After completion of study intervention, patients are followed up at 3, 6, and 12-months.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Random assignments will be concealed from participants and research staff throughout the trial.

Study Groups

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Arm I (iCanQuit app)

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 for at least 45 days on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Ancillary studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Use iCanQuit smartphone app

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (NCI QuitGuide app)

Participants use the NCI QuitGuide app for at least 45 days on study.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Ancillary studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Use NCI QuitGuide smartphone app

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Ancillary studies

Intervention Type PROCEDURE

Smoking Cessation Intervention

Use iCanQuit smartphone app

Intervention Type BEHAVIORAL

Smoking Cessation Intervention

Use NCI QuitGuide smartphone app

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Smoking and Tobacco Use Cessation Interventions Smoking and Tobacco Use Cessation Interventions

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes