An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Fred Hutchinson Cancer Center1,647 enrolled

Overview

This phase III trial compares two remote digital smoking cessation programs to see how well they work for quitting smoking.

OUTLINE: Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program. GROUP I: Experimental QuitBot chatbot program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months. GROUP II: Control SmokefreeTXT text messaging program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,647

Conditions

Smoking &Amp; Tobacco Cessation

Interventions

Experimental Smoking Cessation ProgramOTHER

Participate in Quitbot experimental cessation program

Control Smoking Cessation ProgramOTHER

Participate in Quitbot control cessation program

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or older * Smokes at least one cigarette a day for the past 12 months * Wants to quit cigarette smoking within the next 30 days (consistent with text messaging intervention trials) * If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days * Interested in learning skills to quit smoking * Willing to be randomly assigned to either intervention * Resides in United States (US) and will continue to reside in the US for the next 12 months * Has at least daily access to their own smartphone * Has text messaging on their smartphone and knows how to download a smartphone application * Willing and able to read in English, and * Not using other smoking cessation interventions (This eligibility requirement helps ensure results are due to the treatments we recommend rather than those that participants are doing on their own.) Exclusion Criteria: * The reverse of the inclusion criteria

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Number of Participants With 30-day Cigarette Smoking Cessation

The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 12 months post-randomization. At 12 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.

Time frame: At 12 months after randomization

Secondary Outcomes

Number of Participants With 30-day Cigarette Smoking Cessation

The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 6 months post-randomization. At 6 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.

Time frame: At 6 months after randomization

Data from ClinicalTrials.gov

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