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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 : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE September 17, 2018
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
30-day point prevalence abstinence [ Time Frame: 3 months post randomization ]
No smoking in the past 30 days, as reported 3 month post treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03585231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Trial of the First Conversational Agent for Smoking Cessation (QuitBot)
Official Title  ICMJE Say "Hello" To Your Digital Coach: Development and Pilot Trial of the First Conversational Agent for Smoking Cessation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Behavioral: Immediate access to novel messaging program intervention
    The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.
  • Behavioral: Immediate access to standard of care messaging program intervention
    The immediate control intervention uses a standard of care messaging program for smoking cessation.
  • Behavioral: Delayed access to novel novel messaging program intervention
    The delayed control intervention uses the novel messaging program for smoking cessation.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Immediate access to novel messaging program intervention
  • 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.
    Intervention: Behavioral: Immediate access to standard of care messaging program intervention
  • 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.
    Intervention: Behavioral: Delayed access to novel novel messaging program intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2019)
415
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
300
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585231
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Bricker, PhD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP