A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Smoking Cessation Intervention, Smoking Cessation Intervention, Survey Administration.
- Who it may be relevant to
- Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial (IndigeQuit)
Overview
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.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the IndigeQuit 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.
Interventions
- Procedure Biospecimen Collection
Ancillary studies - Behavioral Smoking Cessation Intervention
Use IndigeQuit smartphone app - Behavioral Smoking Cessation Intervention
Use NCI QuitGuide smartphone app - Other Survey Administration
Ancillary studies
Primary outcome measures
- 30-day point prevalence abstinence (PPA) [Time frame: At 12 months post randomization]
Secondary outcome measures (3)
- 30-day PPA [Time frame: At 3- and 6-months post randomization]
- Self-reported 24-hour PPA [Time frame: At the 3, 6, and 12-month follow-ups]
- Self-reported 7-day PPA [Time frame: At the 3, 6, and 12-month follow-ups]
Eligibility criteria
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) AI/AN 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Publications
- Bricker JB, Santiago-Torres M, Sullivan BM, Mull KE, Clark HW, Fogel CA, Hwang SB, Keith AR, Kornacki C, Afraid Of Lightning-Craddock T, Martinez SA, Seneca DS, Stanford CM, Terry C, Wilcox SL, Nelson L, Henderson PN. Development of a Culturally Adapted Smartphone App (IndigeQuit) Designed to Help American Indian and Alaska Native People Quit Commercial Cigarettes: User-Centered Mixed Methods Stud PMID 41875428
Identifiers
NCT: NCT06145763 · RG1123796 · NCI-2023-09049 · 20279 · R01CA284687