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An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04308759
Collaborator
National Cancer Institute (NCI) (NIH)
1,520
Enrollment
1
Location
2
Arms
32.2
Anticipated Duration (Months)
47.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: QuitBot Smoking Cessation Program
  • Other: Texting Smoking Cessation Program
 Phase 3

Detailed Description

OUTLINE:

Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program.

GROUP I: Quitbot program, which involves prompted and focused conversations for 42 days.

GROUP II: Texting program, which involves quit smoking messages for 42 days. After the completion of study, patients are followed up at 3, 6, and 12 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1520 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Full Scale Randomized Trial of an Innovative Conversational Agent for Smoking Cessation (QuitBot)
Actual Study Start Date :
Jul 24, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (Quitbot)

Participants participate in the Quitbot program which involves prompted, focused conversations for 42 days. Therapy description withheld to protect the integrity of the study.

Other: QuitBot Smoking Cessation Program
Participate in Quitbot experimental cessation program
Other Names:
  • QuitBot

    		•
    Active Comparator: Group II (Texting)

    Participants participate in texting program over 42 days where they receive messages to support quitting smoking. Therapy description withheld to protect the integrity of the study.

    Other: Texting Smoking Cessation Program
    Participate in Texting program
    Other Names:
  • Texting
  • Text
  • Texting program

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with 30-day biochemically confirmed cigarette smoking cessation [At 12 months after randomization]

      No smoking at all in the past 30 or more days. Will measure expired carbon monoxide (CO) by using the CO monitor Bedfont iCO Smokerlyzer.

    Secondary Outcome Measures

    1. Number of participants with 30-day biochemically confirmed cigarette smoking cessation [At 3 and 6 months after randomization]

      No smoking at all in the past 30 or more days. Will measure expired carbon monoxide (CO) by using the CO monitor Bedfont iCO Smokerlyzer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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 both text messaging and Facebook messenger (FM) on their smartphone

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jonathan B. Bricker, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04308759
    Other Study ID Numbers:
    • RG1006844
    • NCI-2020-00136
    • RG1006844
    • R01CA247156
    • 10359
    First Posted:
    Mar 16, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fred Hutchinson Cancer Center
    Smoking
    smoking cessation
    quitting smoking
    chatbot

    Study Results

    No Results Posted as of Aug 15, 2022