Tobacco Use CessationNCT02099097
Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
A study testing web-based video game (Quit IT), Questionnaires and Salvia sample 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 develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- web-based video game (Quit IT), Questionnaires and Salvia sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2014to 24 Dec 2020
- 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
- Age ≥ 18 years old
- English-speaking
- Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
- Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at MSKCC as per the patients clinical team
- Referred to MSK's Tobacco Cessation Program
- Patient-reported cigarette use within the past 30 days
- Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
- Can be reached by telephone
Who cannot join
- Distant metastatic disease at the time of enrollment
- Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
- Any patients who are unable to comply with the study procedures as determined by the study investigators
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 develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.
- Conditions
- Tobacco Use Cessation
- Being tested
- web-based video game (Quit IT), Questionnaires, Salvia sample
- Keywords
- 3D Coping Skills Game, Quit smoking, 14-062
- 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
In order to maximize survey the response rate, patients will be mailed a reminder letter approximately two weeks before the 1 month follow up surveys are due. If the survey is not returned, patients will be sent additional reminders on the survey due date as well as two weeks past the due date.
Salvia sampleOther
The investigators will inform patients prior to obtaining their self-reports that a saliva test or expired CO sample for those using NRT or electronic cigarettes will be performed to examine recent tobacco exposure.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | usual care, which consists of four (face-to-face or telephone) counseling sessions with a trained nurse who has expertise in helping cancer patients quit smoking. This is the same as the treatment an MSK patient who enrolls in the MSK smoking cessation program would receive.
To collect further data to improve the game intervention, the investigators will conduct semi-structured telephone interviews with patients who were randomized to the treatment arm but did not play the game during the one month intervention period. The purpose of the interviews is to elicit qualitative feedback on any barriers that may have prevented participants from playing. At the completion of the intervention period, patients will be asked if they would like to participate in a telephone interview. Telephone interviews will take about twenty minutes and will be held at a time that is convenient for the patient. Receives: Behavioral: Questionnaires; Other: Salvia sample |
| Smoking Cues Coping Skills Game (SC+SCCS/Quit IT). | Experimental | Smokers randomly assigned to SC+SCCS/Quit IT will receive all the components of Standard Care. The patient will be oriented and trained face-to-face (during their hospitalization) on use of the game by study staff using an iPad. The orientation and training session will comprise: 1) Overview of the game and its objectives; 2) discussion of the rules of the game; 3) watching a 10 minute tutorial given by the game narrator (avatar); 4) answering all patient questions; and 5) evaluation of the patient's comprehension of game play via a 17 question survey. Once patients have access to QuitIT, they will also receive a set of Coping Cards Receives: Other: web-based video game (Quit IT); Behavioral: Questionnaires; Other: Salvia sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
quitting smoking self-efficacy
as measured by the Confidence Questionnaire to assess changes in confidence in being able to resist urges to smoke across everyday situations.
Measured: 1 year
Secondary outcomes (1)
efficacy of the game
on smoking abstinence and relapse prevention. We will examine time to smoking relapse following hospitalization, measured as part of the follow-up Smoking Status 1 month following enrollment. We will also biochemically verify 7-day point prevalence smoking abstinence at the 1 month follow-up assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study start24 Mar 2014
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Muzzy Lane Software
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099097
- Sponsor's protocol ID
- 14-062
- Status last verified
- Dec 2020
- First submitted
- 25 Mar 2014
- Last updated
- 30 Dec 2020
- Results posted
- No
Publications
Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.
PubMed 38770804
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
- ClinicalTrials.gov ID
- NCT02099097
- Acronym / sponsor ID
- 14-062
- Conditions
- Tobacco Use Cessation
- Keywords
- 3D Coping Skills Game, Quit smoking, 14-062
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- New York University, Muzzy Lane Software
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 28 Mar 2014 (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 develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Questionnaires, Other: Salvia sampleusual care, which consists of four (face-to-face or telephone) counseling sessions with a trained nurse who has expertise in helping cancer patients quit smoking. This is the same as the treatment an MSK patient who enrolls in the MSK smoking cessation program would receive. To collect further data to improve the game intervention, the investigators will conduct semi-structured telephone interviews with patients who were randomized to the treatment arm but did not play the game during the one month intervention period. The purpose of the interviews is to elicit qualitative feedback on any barriers that may have prevented participants from playing. At the completion of the intervention period, patients will be asked if they would like to participate in a telephone interview. Telephone interviews will take about twenty minutes and will be held at a time that is convenient for the patient. |
| Smoking Cues Coping Skills Game (SC+SCCS/Quit IT). | Experimental | Other: web-based video game (Quit IT), Behavioral: Questionnaires, Other: Salvia sampleSmokers randomly assigned to SC+SCCS/Quit IT will receive all the components of Standard Care. The patient will be oriented and trained face-to-face (during their hospitalization) on use of the game by study staff using an iPad. The orientation and training session will comprise: 1) Overview of the game and its objectives; 2) discussion of the rules of the game; 3) watching a 10 minute tutorial given by the game narrator (avatar); 4) answering all patient questions; and 5) evaluation of the patient's comprehension of game play via a 17 question survey. Once patients have access to QuitIT, they will also receive a set of Coping Cards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- English-speaking
- Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
- Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at MSKCC as per the patients clinical team
- Referred to MSK's Tobacco Cessation Program
Key exclusion criteria (3 listed)
- Distant metastatic disease at the time of enrollment
- Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
- Any patients who are unable to comply with the study procedures as determined by the study investigators
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 | Smoking Cues Coping Skills Game (SC+SCCS/Quit IT). |
| QuestionnairesIn order to maximize survey the response rate, patients will be mailed a reminder letter approximately two weeks before the 1 month follow up surveys are due. If the survey is not returned, patients will be sent additional reminders on the survey due date as well as two weeks past the due date. | Behavioural | Smoking Cues Coping Skills Game (SC+SCCS/Quit IT)., Standard Care |
| Salvia sampleThe investigators will inform patients prior to obtaining their self-reports that a saliva test or expired CO sample for those using NRT or electronic cigarettes will be performed to examine recent tobacco exposure. | Other | Smoking Cues Coping Skills Game (SC+SCCS/Quit IT)., Standard Care |
Primary outcome
quitting smoking self-efficacy
Time frame: 1 year
as measured by the Confidence Questionnaire to assess changes in confidence in being able to resist urges to smoke across everyday situations.
1 secondary outcome
efficacy of the game
Time frame: 1 year
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 30 Dec 2020.
- Derived from this study: PubMed 38770804Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.
- 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 Salvia sample 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 8 inclusion and 3 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 30 Dec 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?
quitting smoking self-efficacy (time frame: 1 year). 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 NCT02099097, 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 30 Dec 2020.