Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00136 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1006844 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA247156 | U.S. NIH Grant/Contract | View source | |
| 10359 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (QuitBot Experimental) | Experimental | Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation. |
|
| Group II (SmokefreeTXT Control) | Active Comparator | Participants participate in the SmokefreeTXT program for 42 days to support quitting smoking. SmokefreeTXT is a standard of care smoking cessation text messaging program from the NCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Smoking Cessation Program | Other | Participate in Quitbot experimental cessation program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan B. Bricker | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39490766 | Background | Bricker JB, Sullivan BM, Mull KE, Lavista-Ferres J, Santiago-Torres M. Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial. Contemp Clin Trials. 2024 Dec;147:107727. doi: 10.1016/j.cct.2024.107727. Epub 2024 Oct 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Adults who smoke were recruited nationally from 07/24/2022 to 01/25/2024 via Facebook ads, search engine results, and referral from friend and family.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group II (SmokefreeTXT Control) | Participants participate in the SmokefreeTXT program for 42 days to support quitting smoking. SmokefreeTXT is a standard of care smoking cessation text messaging program from the NCI. |
| FG001 | Group I (QuitBot Experimental) | Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-Month Follow-up Survey |
|
| ||||||||||||||||||
| 6-Month Follow-up Survey |
| |||||||||||||||||||
| 12-Month Follow-up Survey |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group II (SmokefreeTXT Control) | Participants participate in the SmokefreeTXT program for 42 days to support quitting smoking. SmokefreeTXT is a standard of care smoking cessation text messaging program from the NCI. |
| BG001 | Group I (QuitBot Experimental) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | At 12 months after randomization |
|
12 months post-baseline randomization.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participation in the research. Examples for this trial are increase in depressive symptoms or a suicide attempt.
Three types of adverse event data are to be reported: "All-Cause Mortality," "Serious," and "Other (Not Including Serious)" Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (QuitBot Experimental) | Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation. Experimental Smoking Cessation Program: Participate in Quitbot experimental cessation program |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Bricker | Fred Hutchinson Cancer Center | 206-667-5074 | jbricker@fredhutch.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2024 | Apr 7, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2022 | Mar 7, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Smoking Cessation Program | Other | Participate in Quitbot control cessation program |
|
|
| At 6 months after randomization |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| CESD-20 Depression Screen | Center for Epidemiological Studies Depression 20-item Scale (CESD-20). The range of possible CESD-20 scores is 0-60, with higher values indicating increased symptom severity. | Count of Participants | Participants |
|
| Smoking Level | Count of Participants | Participants |
|
| OG001 | Group I (QuitBot Experimental) | Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 6 months after randomization |
|
|
|
|
| 0 |
| 821 |
| 0 |
| 821 |
| 0 |
| 821 |
| EG001 | Group II (SmokefreeTXT Control) | Participants participate in the QuitBot control SmokefreeTXT program for 42 days to support quitting smoking. SmokefreeTXT is a standard of care smoking cessation text messaging program from the NCI. Control Smoking Cessation Program: Participate in Quitbot control cessation program | 0 | 826 | 0 | 826 | 0 | 826 |
Not provided
Not provided