Cigarette Smoking-Related CarcinomaNCT04510077
SmartQuit Program for Smoking Cessation
A study testing SmartQuit Smoking and Tobacco Cessation Program and Survey Administration in people with Cigarette Smoking-Related Carcinoma and Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma, Tobacco-Related Carcinoma
- What is being tested?
- SmartQuit Smoking and Tobacco Cessation Program and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2014to 11 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the detailed description
OUTLINE:
Patients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months.
- Being tested
- SmartQuit Smoking and Tobacco Cessation Program, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartQuit Smoking and Tobacco Cessation ProgramBehavioural
Also called 2Morrow, SmartQuit
Use SmartQuit program
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (SmartQuit) | Experimental | Patients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months. Receives: Behavioral: SmartQuit Smoking and Tobacco Cessation Program; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 7-day cigarette smoking cessation at 2 months.
No smoking at all in the past 7 or more days (7-day point prevalence quit rate).
Measured: At 2 month follow-up
Secondary outcomes (9)
24-hour point prevalence quit rate
Measured: At 2 month follow-up
Change in number of cigarettes smoked per day
Measured: At 2 month follow-up
Number of intentional 24-hour quit attempts
Measured: At 2 month follow-up
Change in readiness to quit
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
Measured: At 2 month follow-up
Nicotine dependence level
Participants will share their nicotine dependence level via survey at their 2 month follow-up
Measured: At 2 month follow-up
Number of times logged into the application
Will be assessed via 2 month follow-up survey
Measured: At 2 month follow-up
Time spent on the application
Will be assessed via 2 month follow-up survey
Measured: At 2 month follow-up
Participant satisfaction with the application
Will be assessed via 2 month follow-up survey
Measured: At 2 month follow-up
Participant opinion of the usefulness of the application for quitting smoking
Will be assessed via 2 month follow-up survey
Measured: At 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start22 Oct 2014
- Primary completion31 May 2015
- Study completion11 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Life Sciences Discovery Fund
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510077
- Sponsor's protocol ID
- RG1001139
- Other IDs
- NCI-2020-05658, 8287
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of SmartQuit, a Smartphone-Based Smoking Cessation Program
- ClinicalTrials.gov ID
- NCT04510077
- Acronym / sponsor ID
- RG1001139
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Life Sciences Discovery Fund
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 31 May 2015 (actual)
- Study completion
- 11 Aug 2015 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE:
Patients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (SmartQuit) | Experimental | Behavioral: SmartQuit Smoking and Tobacco Cessation Program, Other: Survey AdministrationPatients use the SmartQuit program to learn and practice skill modules as often as they wish over 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartQuit Smoking and Tobacco Cessation ProgramAlso: 2Morrow, SmartQuitUse SmartQuit program | Behavioural | Prevention (SmartQuit) |
| Survey AdministrationAncillary studies | Other | Prevention (SmartQuit) |
Primary outcome
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).
9 secondary outcomes
24-hour point prevalence quit rate
Time frame: At 2 month follow-up
Change in number of cigarettes smoked per day
Time frame: At 2 month follow-up
Number of intentional 24-hour quit attempts
Time frame: At 2 month follow-up
Change in readiness to quit
Time frame: At 2 month follow-up
Nicotine dependence level
Time frame: At 2 month follow-up
Number of times logged into the application
Time frame: At 2 month follow-up
Time spent on the application
Time frame: At 2 month follow-up
Participant satisfaction with the application
Time frame: At 2 month follow-up
Participant opinion of the usefulness of the application for quitting smoking
Time frame: At 2 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Bricker principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartQuit Smoking and Tobacco Cessation Program and Survey Administration in people with Cigarette Smoking-Related Carcinoma and Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 7-day cigarette smoking cessation at 2 months. (time frame: At 2 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.