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

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ClinicalTrials.gov Identifier: NCT03585231
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Say "Hello" To Your Digital Coach: Development and Pilot Trial of the First Conversational Agent for Smoking Cessation
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 30-day point prevalence abstinence [ Time Frame: 3 months post randomization ]
    No smoking in the past 30 days, as reported 3 month post treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585231


Locations
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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Jonathan Bricker, PhD Fred Hutchinson Cancer Research Center

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03585231     History of Changes
Other Study ID Numbers: 8659
NCI-2018-03684 ( Registry Identifier: NCI / CTRP )
RG1001766 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
8659 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Hutchinson Cancer Research Center:
Smoking
Chatbot
Conversational agent
Chatbot for quitting smoking
Messaging
Text messaging
SMS