R01CA284687
Project Grant
Overview
Grant Description
Digital smoking cessation intervention for nationally-recruited American Indians and Alaska Natives: A full-scale randomized controlled trial - Project summary/abstract (description)
Since the early 1980s, American Indians and Alaska Natives (AIANs) have maintained the highest rates of commercial cigarette smoking of any racial/ethnic group in the US. Currently, 27% of AIANs smoke cigarettes. Compared to other racial/ethnic groups, they have 6 times higher rates of developing smoking-related cancers. AIANs are only half as likely to quit smoking compared to other races/ethnicities. The result is that commercial cigarette smoking accounts for half of all deaths among AIANs nationwide.
A major cause of these longstanding inequities is the lack of access to efficacious smoking cessation interventions among AIANs. Compounding the barrier of lack of access to smoking cessation interventions is the barrier of lack of research on the efficacy of smoking cessation interventions for AIANs. Despite having the highest smoking prevalence of any racial/ethnic group in the US for over 40 years, a mere 0.3% of all full-scale smoking cessation randomized controlled trials (RCTs) have focused on AIANs.
Regarding accessibility, a smartphone application ("app") has the potential to deliver a low-cost smoking cessation intervention with wide geographic reach to AIANs and in regions of the US with smoking rates as high as 57% in this group (i.e., Northern Plains). Regarding efficacy, our preliminary data provides promising evidence for our Acceptance and Commitment Therapy (ACT)-based smartphone app, called iCanQuit, to help AIANs quit smoking. We compared the iCanQuit app with the NCI's QuitGuide app among the AIAN subsample (N = 165 recruited from 32 US states) enrolled in our full-scale RCT. This secondary analysis of AIANs showed descriptively higher rates of smoking cessation at the 12-month follow-up (30% for iCanQuit vs. 18% for QuitGuide; OR = 1.96; 95% CI = 0.90, 4.26, p = .089). While encouraging, analyses were exploratory, non-significant, and not a substitute for a full-scale efficacy test.
To address weaknesses of prior research, a fully-powered comparative efficacy RCT of iCanQuit vs. QuitGuide focusing nationwide on AIANs who smoke is now needed. Thus, the goal of this project is to conduct a nationally recruited and fully-powered two-arm RCT comparing iCanQuit (N = 388) to QuitGuide (N = 388), in order to determine: (1) the efficacy of iCanQuit relative to the QuitGuide app for biochemically verified 30-day point prevalence abstinence (PPA) at 12 months post-randomization and (2) whether iCanQuit's (but not QuitGuide's) 12-month smoking cessation outcomes are significantly mediated by improvements in core ACT-based processes.
This study will be the first full-scale RCT of a digital intervention for helping AIANs nationwide stop smoking. Qualitative interviews with (1) a subsample of iCanQuit participants to thematize testimonials of their experience with iCanQuit and (2) AIAN members from our study Community Advisory Board (CAB) will guide our plan for broadly disseminating iCanQuit to AIAN adults nationwide.
Positive results would improve health equity by providing a highly accessible and efficacious intervention with potential for sustainability and broad dissemination for AIANs nationwide.
Since the early 1980s, American Indians and Alaska Natives (AIANs) have maintained the highest rates of commercial cigarette smoking of any racial/ethnic group in the US. Currently, 27% of AIANs smoke cigarettes. Compared to other racial/ethnic groups, they have 6 times higher rates of developing smoking-related cancers. AIANs are only half as likely to quit smoking compared to other races/ethnicities. The result is that commercial cigarette smoking accounts for half of all deaths among AIANs nationwide.
A major cause of these longstanding inequities is the lack of access to efficacious smoking cessation interventions among AIANs. Compounding the barrier of lack of access to smoking cessation interventions is the barrier of lack of research on the efficacy of smoking cessation interventions for AIANs. Despite having the highest smoking prevalence of any racial/ethnic group in the US for over 40 years, a mere 0.3% of all full-scale smoking cessation randomized controlled trials (RCTs) have focused on AIANs.
Regarding accessibility, a smartphone application ("app") has the potential to deliver a low-cost smoking cessation intervention with wide geographic reach to AIANs and in regions of the US with smoking rates as high as 57% in this group (i.e., Northern Plains). Regarding efficacy, our preliminary data provides promising evidence for our Acceptance and Commitment Therapy (ACT)-based smartphone app, called iCanQuit, to help AIANs quit smoking. We compared the iCanQuit app with the NCI's QuitGuide app among the AIAN subsample (N = 165 recruited from 32 US states) enrolled in our full-scale RCT. This secondary analysis of AIANs showed descriptively higher rates of smoking cessation at the 12-month follow-up (30% for iCanQuit vs. 18% for QuitGuide; OR = 1.96; 95% CI = 0.90, 4.26, p = .089). While encouraging, analyses were exploratory, non-significant, and not a substitute for a full-scale efficacy test.
To address weaknesses of prior research, a fully-powered comparative efficacy RCT of iCanQuit vs. QuitGuide focusing nationwide on AIANs who smoke is now needed. Thus, the goal of this project is to conduct a nationally recruited and fully-powered two-arm RCT comparing iCanQuit (N = 388) to QuitGuide (N = 388), in order to determine: (1) the efficacy of iCanQuit relative to the QuitGuide app for biochemically verified 30-day point prevalence abstinence (PPA) at 12 months post-randomization and (2) whether iCanQuit's (but not QuitGuide's) 12-month smoking cessation outcomes are significantly mediated by improvements in core ACT-based processes.
This study will be the first full-scale RCT of a digital intervention for helping AIANs nationwide stop smoking. Qualitative interviews with (1) a subsample of iCanQuit participants to thematize testimonials of their experience with iCanQuit and (2) AIAN members from our study Community Advisory Board (CAB) will guide our plan for broadly disseminating iCanQuit to AIAN adults nationwide.
Positive results would improve health equity by providing a highly accessible and efficacious intervention with potential for sustainability and broad dissemination for AIANs nationwide.
Awardee
Funding Goals
TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Seattle,
Washington
981094433
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 375% from $744,186 to $3,532,837.
Fred Hutchinson Cancer Center was awarded
Digital Smoking Cessation for AIANs: RCT of iCanQuit vs. QuitGuide
Project Grant R01CA284687
worth $3,532,837
from National Cancer Institute in September 2023 with work to be completed primarily in Seattle Washington United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.393 Cancer Cause and Prevention Research.
The Project Grant was awarded through grant opportunity Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required).
Status
(Ongoing)
Last Modified 9/24/25
Period of Performance
9/20/23
Start Date
8/31/28
End Date
Funding Split
$3.5M
Federal Obligation
$0.0
Non-Federal Obligation
$3.5M
Total Obligated
Activity Timeline
Transaction History
Modifications to R01CA284687
Additional Detail
Award ID FAIN
R01CA284687
SAI Number
R01CA284687-3990948866
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
TJFZLPP6NYL6
Awardee CAGE
50WB4
Performance District
WA-07
Senators
Maria Cantwell
Patty Murray
Patty Murray
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) | Health research and training | Grants, subsidies, and contributions (41.0) | $744,186 | 100% |
Modified: 9/24/25