Tobacco Use CessationNCT01915836
Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
A study testing web-based video game (Quit IT), Questionnaires and Evaluation Interview in people with Tobacco Use Cessation, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- web-based video game (Quit IT), Questionnaires and Evaluation Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2014
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated by the MSKCC Tobacco Cessation Program
- At least 30 years of age
Who cannot join
- Insufficient manual dexterity and vision to use a computer and mouse as per self-report
- Unstable medical or psychiatric condition as determined by the PI and Co-PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game.
- Conditions
- Tobacco Use Cessation
- Being tested
- web-based video game (Quit IT), Questionnaires, Evaluation Interview
- Keywords
- 11-043, MSKCC Tobacco Cessation Program
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based video game (Quit IT)Other
QuestionnairesBehavioural
Evaluation InterviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Alpha game testers and questionaires | Experimental | This a video game designed to help smokers quit \& remain non-smokers. Before the start the game,the participant will fill out a brief questionnaire.
It should take about 5 minutes to complete. Once this is done, the game play should last about 30 minutes \& will present with different scenes. These scenes will show situations that may trigger smoking urges such as walking into a room where another person is smoking. In the game, the participant will be able to use different ways of coping with urges to smoke such as taking several deep breaths or listening to music. The participant will be asked to talk aloud about what they think of the game. The participant will be video \&/or audio recorded while doing this. Once finished testing the game, we will then ask you a few questions about what you thought of the game. We will also ask you how relevant different situations are to you as a smoker or someone who is trying to avoid smoking. The entire visit is expected to last about 1.5 hours. Receives: Other: web-based video game (Quit IT); Behavioral: Questionnaires; Behavioral: Evaluation Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability (10-item Game Usability Scale)
we will ask each participant to complete a Game Usability Scale3 which is a robust and highly recommended 10-item measure of usability developed for software testing that provides a global view of subjective assessments of usability.
Measured: 1 time
Satisfaction
(users' subjective reactions to using the system) After the game play session, we will have participants complete an Avatar and Situation Menu Questionnaire so that participants can give feedback on 3 different avatars and 15 different coping with smoking challenges regarding how relevant each is to them as a smoker or someone trying to avoid smoking.
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Muzzy Lane Software
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915836
- Sponsor's protocol ID
- 11-043
- Status last verified
- Dec 2014
- First submitted
- 1 Aug 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
Publications
Krebs P, Burkhalter J, Fiske J, Snow H, Schofield E, Iocolano M, Borderud S, Ostroff JS. The QuitIT Coping Skills Game for Promoting Tobacco Cessation Among Smokers Diagnosed With Cancer: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10071. doi: 10.2196/10071.
PubMed 30632971
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
- ClinicalTrials.gov ID
- NCT01915836
- Acronym / sponsor ID
- 11-043
- Conditions
- Tobacco Use Cessation
- Keywords
- 11-043, MSKCC Tobacco Cessation Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Muzzy Lane Software
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- 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.
The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha game testers and questionaires | Experimental | Other: web-based video game (Quit IT), Behavioral: Questionnaires, Behavioral: Evaluation InterviewThis a video game designed to help smokers quit \& remain non-smokers. Before the start the game,the participant will fill out a brief questionnaire. It should take about 5 minutes to complete. Once this is done, the game play should last about 30 minutes \& will present with different scenes. These scenes will show situations that may trigger smoking urges such as walking into a room where another person is smoking. In the game, the participant will be able to use different ways of coping with urges to smoke such as taking several deep breaths or listening to music. The participant will be asked to talk aloud about what they think of the game. The participant will be video \&/or audio recorded while doing this. Once finished testing the game, we will then ask you a few questions about what you thought of the game. We will also ask you how relevant different situations are to you as a smoker or someone who is trying to avoid smoking. The entire visit is expected to last about 1.5 hours. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated by the MSKCC Tobacco Cessation Program
- At least 30 years of age
Key exclusion criteria (2 listed)
- Insufficient manual dexterity and vision to use a computer and mouse as per self-report
- Unstable medical or psychiatric condition as determined by the PI and Co-PI.
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 |
|---|---|---|
| web-based video game (Quit IT) | Other | Alpha game testers and questionaires |
| Questionnaires | Behavioural | Alpha game testers and questionaires |
| Evaluation Interview | Behavioural | Alpha game testers and questionaires |
Primary outcome
Usability (10-item Game Usability Scale)
Time frame: 1 time
we will ask each participant to complete a Game Usability Scale3 which is a robust and highly recommended 10-item measure of usability developed for software testing that provides a global view of subjective assessments of usability.
Satisfaction
Time frame: 1 time
(users' subjective reactions to using the system) After the game play session, we will have participants complete an Avatar and Situation Menu Questionnaire so that participants can give feedback on 3 different avatars and 15 different coping with smoking challenges regarding how relevant each is to them as a smoker or someone trying to avoid smoking.
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 11 Dec 2014.
- Derived from this study: PubMed 30632971Krebs P, Burkhalter J, Fiske J, Snow H, Schofield E, Iocolano M, Borderud S, Ostroff JS. The QuitIT Coping Skills Game for Promoting Tobacco Cessation Among Smokers Diagnosed With Cancer: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10071. doi: 10.2196/10071.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based video game (Quit IT), Questionnaires and Evaluation Interview in people with Tobacco Use Cessation, run by Memorial Sloan Kettering 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 2 inclusion and 2 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 11 Dec 2014. 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?
Usability (10-item Game Usability Scale) (time frame: 1 time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915836, which also lists 1 linked publication.
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 11 Dec 2014.