An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Active, not recruiting; Phase 3

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Other: Experimental Smoking Cessation Program; Other: Control Smoking Cessation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04308759

NCI-2020-00136 (Registry Identifier)

10359 (Other Grant/Funding Number)

RG1006844 (Other Identifier)

R01CA247156 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

OUTLINE:

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

GROUP I: Experimental 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 program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Enrollment: 1,647 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,647 participants in 2 patient groups

Group I (QuitBot Experimental)

Experimental group

Description:

Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Treatment:

Other: Experimental Smoking Cessation Program

Group II (QuitBot Control)

Active Comparator group

Description:

Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Treatment:

Other: Control Smoking Cessation Program