- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510077
SmartQuit Program for Smoking Cessation
August 10, 2020 updated by: Fred Hutchinson Cancer Center
Study of SmartQuit, a Smartphone-Based Smoking Cessation Program
This trial investigates how well a smartphone-based smoking cessation program called SmartQuit works to help patients stop smoking.
SmartQuit is an smartphone application-based smoking cessation program that includes a defined program consisting of interactive evidence-based exercises for dealing more effectively with urges to smoke, a place to track desired behaviors, personalized plans for quitting, and a certificate of completion once the recommended program components are completed.
SmartQuit may help patients quit smoking, lower healthcare costs and reduce premature tobacco-related deaths.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
OUTLINE:
Patients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smokes at least five cigarettes daily for at least past 12 months
- Wants to quit in the next 30 days
- Interested in learning skills to quit smoking
- Resides in United States (US)
- Has at least daily access to their own smartphone
- Knows how to login and download a smartphone application from their smartphone
- Willing and able to read in English
- Not participating in other smoking cessation interventions (including our other intervention studies)
- Must be an employee of a company who is participating in recruitment
- Willing to complete one follow-up survey
- Provide email, phone, and mailing address
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Prevention (SmartQuit)
Patients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months.
|
Ancillary studies
Use SmartQuit program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with 7-day cigarette smoking cessation at 2 months.
Time Frame: At 2 month follow-up
|
No smoking at all in the past 7 or more days (7-day point prevalence quit rate).
|
At 2 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-hour point prevalence quit rate
Time Frame: At 2 month follow-up
|
At 2 month follow-up
|
|
|
Change in number of cigarettes smoked per day
Time Frame: At 2 month follow-up
|
At 2 month follow-up
|
|
|
Number of intentional 24-hour quit attempts
Time Frame: At 2 month follow-up
|
At 2 month follow-up
|
|
|
Change in readiness to quit
Time Frame: At 2 month follow-up
|
Differences in a participant's readiness to quit will be assessed by comparing their responses to the baseline survey readiness to quit questions with their responses to the 2 month follow-up survey
|
At 2 month follow-up
|
|
Nicotine dependence level
Time Frame: At 2 month follow-up
|
Participants will share their nicotine dependence level via survey at their 2 month follow-up
|
At 2 month follow-up
|
|
Number of times logged into the application
Time Frame: At 2 month follow-up
|
Will be assessed via 2 month follow-up survey
|
At 2 month follow-up
|
|
Time spent on the application
Time Frame: At 2 month follow-up
|
Will be assessed via 2 month follow-up survey
|
At 2 month follow-up
|
|
Participant satisfaction with the application
Time Frame: At 2 month follow-up
|
Will be assessed via 2 month follow-up survey
|
At 2 month follow-up
|
|
Participant opinion of the usefulness of the application for quitting smoking
Time Frame: At 2 month follow-up
|
Will be assessed via 2 month follow-up survey
|
At 2 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 22, 2014
Primary Completion (ACTUAL)
May 31, 2015
Study Completion (ACTUAL)
August 11, 2015
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (ACTUAL)
August 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 10, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1001139
- NCI-2020-05658 (REGISTRY: NCI / CTRP)
- 8287 (OTHER: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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