Clinical trial NCT06145763: A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking
Official title: Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-24
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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) 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

Primary outcomes:
measure: 30-day point prevalence abstinence (PPA)
timeFrame: At 12 months post randomization
Secondary outcomes:
measure: 30-day PPA
timeFrame: At 3- and 6-months post randomization
measure: Self-reported 24-hour PPA
timeFrame: At the 3, 6, and 12-month follow-ups
measure: Self-reported 7-day PPA
timeFrame: At the 3, 6, and 12-month follow-ups
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan B. Bricker
role: PRINCIPAL_INVESTIGATOR
References: