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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145763
• Other study ID #: RG1123796
• Secondary ID: NCI-2023-09049RG
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 30, 2028

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Brie Sullivan
• Phone: 206-667-5238
• Email: bsulliva[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 776
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Ancillary studies

Behavioral:
• Smoking Cessation Intervention
Use iCanQuit smartphone app
• Smoking Cessation Intervention
Use NCI QuitGuide smartphone app

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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