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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03585231
Other study ID # 8659
Secondary ID NCI-2018-03684RG
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2018
Est. completion date December 2, 2020

Study information

Verified date December 2020
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date December 2, 2020
Est. primary completion date December 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Immediate access to novel messaging program intervention
The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.
Immediate access to standard of care messaging program intervention
The immediate control intervention uses a standard of care messaging program for smoking cessation.
Delayed access to novel novel messaging program intervention
The delayed control intervention uses the novel messaging program for smoking cessation.

Locations

Country Name City State
United States Fred Hutchinson Cancer Research Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day point prevalence abstinence No smoking in the past 30 days, as reported 3 month post treatment. 3 months post randomization
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