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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA143188 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The objective of this research is to determine whether smartphone games show promise for helping smokers increase their chances of quitting. The central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Games | Experimental | This arm of the project will address the following question: How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games. |
|
| No Mobile Games | Experimental | This arm of the project will address the following question: How effective is the following intervention: Nicotine patch plus behavioral cessation counseling without access to Mobile Games. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | 4-week starter kit of nicotine patch |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change | Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change. | Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya R. Schlam, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31536384 | Derived | Schlam TR, Baker TB. Playing Around with Quitting Smoking: A Randomized Pilot Trial of Mobile Games as a Craving Response Strategy. Games Health J. 2020 Feb;9(1):64-70. doi: 10.1089/g4h.2019.0030. Epub 2019 Sep 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Games | This arm of the project will address the following question: How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions Mobile Games |
| FG001 | No Mobile Games | This arm of the project will address the following question: How effective is the following intervention: Nicotine patch plus behavioral cessation counseling without access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Games | This arm of the project will address the following question: How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions Mobile Games |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change | Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change. | Posted | Mean | Standard Deviation | percentage change in cigarettes per day | Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline |
|
Adverse event data were collected 3 times during one month of treatment.
Participants were asked "Since your last contact with us, have there been any changes in your medical condition or health?" on the target quit day (TQD), 2 weeks post-TQD, and 4 weeks post-TQD. Only nicotine-related adverse events were counted. A total of 15 nicotine-related adverse events were assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Games | This arm of the project will address the following question: How effective is the following intervention? Nicotine patch plus behavioral cessation counseling with access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions Mobile Games |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanya Schlam, PhD | University of Wisconsin Center for Tobacco Research and Intervention | 608-262-4149 | trschlam@ctri.wisc.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Cessation Counseling |
| Behavioral |
5 brief counseling sessions |
|
| Mobile Games | Device |
|
| No Mobile Games |
This arm of the project will address the following question: How effective is the following intervention: Nicotine patch plus behavioral cessation counseling without access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | No Mobile Games | This arm of the project will address the following question: How effective is the following intervention: Nicotine patch plus behavioral cessation counseling without access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | No Mobile Games | This arm of the project will address the following question: How effective is the following intervention: Nicotine patch plus behavioral cessation counseling without access to Mobile Games. Nicotine patch: 4-week starter kit of nicotine patch Cessation Counseling: 5 brief counseling sessions | 0 | 14 | 0 | 14 | 2 | 14 |
| Itching or hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D001523 |
| Mental Disorders |