Smoking CessationQuitBotNCT03585231
Pilot Trial of the First Conversational Agent for Smoking Cessation (QuitBot)
A study testing Immediate access to novel messaging program intervention and Delayed access to novel novel messaging program intervention in people with Smoking Cessation, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Immediate access to novel messaging program intervention and Delayed access to novel novel messaging program intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- The exclusion criteria are opposite of the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Immediate access to novel messaging program intervention, Immediate access to standard of care messaging program intervention, Delayed access to novel novel messaging program intervention
- Keywords
- Smoking, Chatbot, Conversational agent, Chatbot for quitting smoking, Messaging, Text messaging, SMS
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate access to novel messaging program interventionBehavioural
The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.
Immediate access to standard of care messaging program interventionBehavioural
The immediate control intervention uses a standard of care messaging program for smoking cessation.
Delayed access to novel novel messaging program interventionBehavioural
The delayed control intervention uses the novel messaging program for smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Immediate access to novel messaging program intervention |
| Control | Active comparator | 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. Receives: Behavioral: Immediate access to standard of care messaging program intervention |
| Delayed Control | Active comparator | 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. Receives: Behavioral: Delayed access to novel novel messaging program intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence abstinence
No smoking in the past 30 days, as reported 3 month post treatment.
Measured: 3 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start17 Sep 2018
- Primary completion6 Dec 2019
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585231
- Sponsor's protocol ID
- 8659
- Other IDs
- NCI-2018-03684, RG1001766, 8659
- Acronym
- QuitBot
- Status last verified
- Dec 2020
- First submitted
- 29 Jun 2018
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38913882
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Say "Hello" To Your Digital Coach: Development and Pilot Trial of the First Conversational Agent for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03585231
- Acronym / sponsor ID
- QuitBot / 8659
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Chatbot, Conversational agent, Chatbot for quitting smoking, Messaging, Text messaging, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Immediate access to novel messaging program interventionThis 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. |
| Control | Active comparator | Behavioral: Immediate access to standard of care messaging program interventionThis 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. |
| Delayed Control | Active comparator | Behavioral: Delayed access to novel novel messaging program interventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (1 listed)
- The exclusion criteria are opposite of the inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate access to novel messaging program interventionThe experimental arm includes an immediate intervention using a novel messaging program for smoking cessation. | Behavioural | Experimental |
| Immediate access to standard of care messaging program interventionThe immediate control intervention uses a standard of care messaging program for smoking cessation. | Behavioural | Control |
| Delayed access to novel novel messaging program interventionThe delayed control intervention uses the novel messaging program for smoking cessation. | Behavioural | Delayed Control |
Primary outcome
30-day point prevalence abstinence
Time frame: 3 months post randomization
No smoking in the past 30 days, as reported 3 month post treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 38913882Bricker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Bricker, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate access to novel messaging program intervention and Delayed access to novel novel messaging program intervention in people with Smoking Cessation, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day point prevalence abstinence (time frame: 3 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.