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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study aims to see how feasible a mobile app based virtual reality program for smoking cessation (MindCotine) would be among Stanford cancer center patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MindCotine mobile app program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindCotine's VR app | Behavioral | The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Registered With the MindCotine Application | Total number of patients who registered with the app, out of total number of participants who were enrolled (eligible and willing to accept help with quitting). This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | 6 weeks |
| Number of Patients With Interest in the MindCotine Application | Total number of patients who expressed interest in the app, out of total number of participants who were screened for enrollment. This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | 6 weeks |
| Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke. | Learning whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. Interest in using the app will be calculated as total number of patients who recommend the app to others. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Attempt to Quit Smoking by Using the Application | Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey | 6 weeks prior to end of treatment survey |
| Number of Patients Using Cessation Medication by End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39042439 | Derived | Jackson RW, Cao-Nasalga A, Chieng A, Pirkl A, Jagielo AD, Xu C, Goldenhersch E, Rosencovich N, Waitman C, Prochaska JJ. Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center's Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study. JMIR Form Res. 2024 Jul 23;8:e54817. doi: 10.2196/54817. |
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105 participants were screened for eligibility.
Participants use the app for 6 weeks and complete a final end of treatment survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | MindCotine Mobile App Program | MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MindCotine Mobile App Program | MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy. |
| 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 | Number of Patients Who Registered With the MindCotine Application | Total number of patients who registered with the app, out of total number of participants who were enrolled (eligible and willing to accept help with quitting). This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | Posted | Count of Participants | Participants | 6 weeks |
|
|
9 weeks
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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 | MindCotine Mobile App Program | MindCotine VR app program, a 6-week intervention to help users utilize mindfulness based skills involving virtual exposure therapy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disorientation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Prochaska | Stanford University | (650) 724-3608 | jpro@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 | Oct 26, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2022 | Jun 10, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Number of participants using cessation medications among those who completed the end of treatment survey. |
| 6 weeks |
| Number of MindCotine App Program Activities Completed | Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises. | 6 weeks |
| Number of MindCotine App Journal Entries Completed | Journal Record refers to CBT-based self-reflections. | 6 weeks |
| Number of MindCotine App Coaching Engagements Completed | Coaching Engagement refers to communicating with a coach through the MindCotine mobile application. | 6 weeks |
| Average Change in Cigarette Use | Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app. | baseline to end of treatment, up to 6 weeks |
| MindCotine Dropout | Number of patients who withdrew or were removed from the study. | 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Smoking habit | Count of Participants | Participants |
|
| Cigarette use - patients who smoke every day | Patients who smoke every day | Mean | Standard Deviation | cigarettes per day |
|
| Cigarette use - patients who smoke some days | Patients who smoke some days | Mean | Standard Deviation | cigarettes per week |
|
|
|
| Primary | Number of Patients With Interest in the MindCotine Application | Total number of patients who expressed interest in the app, out of total number of participants who were screened for enrollment. This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | Participants who were screened for eligibility | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Primary | Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke. | Learning whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. Interest in using the app will be calculated as total number of patients who recommend the app to others. | Participants who completed the end of treatment survey. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of Patients Who Attempt to Quit Smoking by Using the Application | Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey | Participants who completed the end of treatment survey. | Posted | Count of Participants | Participants | 6 weeks prior to end of treatment survey |
|
|
|
| Secondary | Number of Patients Using Cessation Medication by End of Treatment | Number of participants using cessation medications among those who completed the end of treatment survey. | Participants who completed the end of treatment survey. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Number of MindCotine App Program Activities Completed | Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises. | Participants who used the app | Posted | Mean | Standard Deviation | activities | 6 weeks |
|
|
|
| Secondary | Number of MindCotine App Journal Entries Completed | Journal Record refers to CBT-based self-reflections. | Participants who used the app | Posted | Mean | Standard Deviation | Journal entries | 6 weeks |
|
|
|
| Secondary | Number of MindCotine App Coaching Engagements Completed | Coaching Engagement refers to communicating with a coach through the MindCotine mobile application. | Participants who used the app | Posted | Mean | Standard Deviation | Coaching engagements | 6 weeks |
|
|
|
| Secondary | Average Change in Cigarette Use | Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app. | patients who used the app | Posted | Mean | Standard Deviation | cigarettes | baseline to end of treatment, up to 6 weeks |
|
|
|
| Secondary | MindCotine Dropout | Number of patients who withdrew or were removed from the study. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Double vision | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Lighheadedness | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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