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NCT06145763 | NOT YET RECRUITING | Cigarette Smoking-Related Carcinoma

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

Fred Hutchinson Cancer Center

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.

Condition or disease

Cigarette Smoking-Related Carcinoma

Intervention/treatment

Biospecimen Collection

Smoking Cessation Intervention

Smoking Cessation Intervention

Survey Administration

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 776 participants
Masking : QUADRUPLE
Masking Description : Random assignments will be concealed from participants and research staff throughout the trial.
Primary Purpose : PREVENTION
Official Title : Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2027-11-30
Estimated Study Completion Date : 2028-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking

Location Details

NCT06145763

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109