- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02099097
Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Care
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. |
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.
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.
|
|
Experimental: Smoking Cues Coping Skills Game (SC+SCCS/Quit IT).
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy of the game
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-062
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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