Pilot Trial of the First Conversational Agent for Smoking Cessation (QuitBot)

NCT ID: NCT03585231

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2020-12-02

Brief Summary

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Conversational agents (CAs) are computer-powered digital coaches designed to form long-term social-emotional connections with users through conversations. We have developed a CA for cigarette smoking cessation. In a pilot randomized trial (N = 415), we will compare the experimental messaging program (n = 155) with the standard of care national government smoking cessation messaging program (n = 157), and then we will compare immediate (n=51) versus delayed (n=51) access to the the experimental messaging program, to assess 12-week usability, receptivity, and preliminary cessation results in adults in western Washington State and nationally across the US who want to quit smoking.

Detailed Description

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Cigarette smoking is the most preventable cause of cancer in the US, accounting for one-third of all cancer deaths. Within the Fred Hutchinson Center's western Washington State 13-county catchment area, there are enormous disparities in adult cigarette smoking rates. Our recently completed WebQuit website RCT for smoking cessation had low engagement and no personalization to users' needs. Fortunately, a potentially game-changing solution to the problems of engagement and lack of personalization provide a new direction for my research. Advances in machine learning, natural language processing, and cloud computing are making it possible to create and widely disseminate conversational agents (CAs), which are computer-powered digital coaches designed to form long-term social-emotional connections with users through conversations. We have developed a CA for cigarette smoking cessation. In a pilot randomized trial (N = 415), we will compare the experimental messaging program with the standard of care national government smoking cessation messaging program, and then we will compare immediate versus delayed access to the the experimental messaging program. Twelve-week usability, receptivity, and preliminary cessation results will provide critical and timely pilot data.

Conditions

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Smoking Cessation

Keywords

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Smoking Chatbot Conversational agent Chatbot for quitting smoking Messaging Text messaging SMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental

This is the experimental arm of the study. This includes receiving immediate access to the novel/experimental smoking cessation messaging program. Therapy description withheld to protect the integrity of the study.

Group Type EXPERIMENTAL

Immediate access to novel messaging program intervention

Intervention Type BEHAVIORAL

The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.

Control

This is the control arm of the study. This includes receiving receiving immediate access to the standard of care smoking cessation messaging program. Therapy description withheld to protect the integrity of the study.

Group Type ACTIVE_COMPARATOR

Immediate access to standard of care messaging program intervention

Intervention Type BEHAVIORAL

The immediate control intervention uses a standard of care messaging program for smoking cessation.

Delayed Control

This is the second control arm of the study. This includes receiving the novel/experimental smoking cessation messaging program after completing the 3-month follow-up survey. Therapy description withheld to protect the integrity of the study.

Group Type ACTIVE_COMPARATOR

Delayed access to novel novel messaging program intervention

Intervention Type BEHAVIORAL

The delayed control intervention uses the novel messaging program for smoking cessation.

Interventions

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Immediate access to novel messaging program intervention

The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.

Intervention Type BEHAVIORAL

Immediate access to standard of care messaging program intervention

The immediate control intervention uses a standard of care messaging program for smoking cessation.

Intervention Type BEHAVIORAL

Delayed access to novel novel messaging program intervention

The delayed control intervention uses the novel messaging program for smoking cessation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 18 or older
* smokes at least five cigarettes daily for at least past 12 months
* wants to quit cigarette smoking in the next 14 days
* if concurrently using any other nicotine or tobacco products, wants to quit using them within the next 14days
* resides in western Washington State (in the following counties: Clallam, Grays Harbor, Island, Jefferson, King, Kitsap, Mason, Pierce, San Juan, Skagit, Snohomish, Thurston, and Whatcom)
* interested in learning skills to quit smoking
* willing to be randomly assigned to either condition
* has at least daily access to their own personal smartphone
* has and uses both text messaging and Facebook Messenger on their smartphone
* willing and able to read in English
* not using other smoking cessation interventions (including apps or our other intervention studies).
* willing to complete one 3-month follow-up survey
* willing to provide email, phone, and mailing address.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Bricker, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Bricker JB, Sullivan B, Mull K, Santiago-Torres M, Lavista Ferres JM. Conversational Chatbot for Cigarette Smoking Cessation: Results From the 11-Step User-Centered Design Development Process and Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 23;12:e57318. doi: 10.2196/57318.

Reference Type DERIVED
PMID: 38913882 (View on PubMed)

Other Identifiers

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NCI-2018-03684

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1001766

Identifier Type: OTHER

Identifier Source: secondary_id

8659

Identifier Type: OTHER

Identifier Source: secondary_id

8659

Identifier Type: -

Identifier Source: org_study_id