A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment in 6 months

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Other: Interview; Procedure: Carbon Monoxide Measurement; Other: Survey Administration; Device: QuitBot Smoking Cessation Chatbot Program; Device: QuitBot Smoking Cessation Text Messaging Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06697496

NCI-2024-08892 (Registry Identifier)

U19MD020533 (U.S. NIH Grant/Contract)

RG1124884

FHIRB0020651 (Other Identifier)

Details and patient eligibility

About

This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.

Full description

OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.

ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

Enrollment: 772 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
• Age 18 and older
• Smoking combustible cigarettes daily in the past year
• Interest in quitting smoking
• Interest in learning skills to quit smoking
• Willing to be randomly assigned
• Have daily access to their own Android or iPhone smartphone
• Ability to download a smartphone app
• Ability to read English
• Not currently (i.e., within past 30 days) using other smoking cessation interventions
• No prior participation in our studies
• No prior use of SFT
• No household or family member participating
• US residency for the next twelve months
• Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
• Providing email, phone number(s), and mailing address

Exclusion criteria

• The reverse of the inclusion criteria
• Pregnant or breastfeeding
• Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

772 participants in 2 patient groups

Arm I (QuitBot chatbot)

Experimental group

Description:

Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.

Treatment:

Procedure: Carbon Monoxide Measurement

Other: Survey Administration

Device: QuitBot Smoking Cessation Chatbot Program

Other: Interview

Arm II (QuitBot texting)

Active Comparator group

Description:

Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.

Treatment:

Device: QuitBot Smoking Cessation Text Messaging Program

Procedure: Carbon Monoxide Measurement

Other: Survey Administration