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

Say "Hello" To Your Digital Coach: Development and Pilot Trial of the First Conversational Agent for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Immediate access to novel messaging program intervention; Behavioral: Immediate access to standard of care messaging program intervention; Behavioral: Delayed access to novel novel messaging program intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

• The exclusion criteria are opposite of the inclusion criteria listed above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Immediate access to novel messaging program intervention; The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.
Active Comparator: 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.	Behavioral: Immediate access to standard of care messaging program intervention; The immediate control intervention uses a standard of care messaging program for smoking cessation.
Active Comparator: 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.	Behavioral: Delayed access to novel novel messaging program intervention; The delayed control intervention uses the novel messaging program for smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day point prevalence abstinence	No smoking in the past 30 days, as reported 3 month post treatment.	3 months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Jonathan Bricker, PhD, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Smoking; SMS; Text messaging; Chatbot; Conversational agent; Chatbot for quitting smoking; Messaging
• Other Study ID Numbers: 8659 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2018-03684 (Registry Identifier: NCI / CTRP); RG1001766 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No