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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This clinical trial compares a new smoking cessation smartphone application (app) (IndigeQuit) to an existing smarphone app (National Cancer Institute \[NCI\] QuitGuide) for helping American Indians and Alaska Natives (AI/ANs) 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. IndigeQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges, staying motivated, and preventing relapse. The IndigeQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Ancillary studies

  • Smoking Cessation Intervention

    Behavioral

    Use IndigeQuit smartphone app

  • Smoking Cessation Intervention

    Behavioral

    Use NCI QuitGuide smartphone app

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

776 Participants
are divided into 2 treatment groups
Group A: Arm I (IndigeQuit app)Experimental treatment 3 interventions
Group B: Arm II (NCI QuitGuide app)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 12 months post randomization

Secondary outcomes

1

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.

Time frame
At 3- and 6-months post randomization
2

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.

Time frame
At the 3, 6, and 12-month follow-ups
3

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.

Time frame
At the 3, 6, and 12-month follow-ups

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator