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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10014 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20697 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA298383 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.
ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
After completion of study intervention, patients may be followed up at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (iCanQuit application) | Experimental | Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. |
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| Arm II (iCanQuit application and NRT) | Experimental | Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCanQuit Smartphone App Smoking Cessation Program | Device | Receive access to iCanQuit app, with daily push notifications |
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| Measure | Description | Time Frame |
|---|---|---|
| 30-day point prevalence abstinence (PPA) | The comparison will use a logistic regression model, following standard intent-to-treat analysis for smoking cessation trials, will be employed, coding all missing outcomes as smoking. The model will adjust for stratification factors and baseline factors that are both imbalanced after randomization and significantly related to the outcome. | At 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day PPA | At 3 and 6 months post randomization | |
| 24 hour PPA | At 3, 6 and 12 months post randomization | |
| 7 day PPA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Bricker, PhD | Contact | 206-667-5074 | jbricker@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bricker, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
The trial results data will be published on ClinicalTrials.gov at the time of study completion. The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified scientific data will be made available as public use data to the research community in openICPSR. Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads. No PII or PHI data will be shared or available for secondary use. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
The trial results data will be published on ClinicalTrials.gov at the time of study completion. The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
The de-identified scientific data will be made available as public use data to the research community in openICPSR. Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads. No PII or PHI data will be shared or available for secondary use.
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| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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To assure blinding, random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by our survey research unit that will be blind to treatment arm
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| Nicotine Gum | Drug | Receive nicotine replacement therapy gum |
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| Nicotine Patch | Drug | Receive nicotine replacement therapy patch(es) |
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| Nicotine Lozenge | Drug | Receive nicotine replacement therapy lozenge(s) |
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| Survey Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| At 3, 6 and 12 months post randomization |
| Cost per quitter | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. The incremental cost-per-quitter will be estimated as the difference in total cost of delivering the two interventions divided by the difference in the number of 30-day abstinent participants at 12 months. | At 12 months post randomization |
| Cost per life year gained | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. To compare iCanQuit with iCanQuit plus NRT in terms of life years gained, researchers will calculate the cost per life year gained. | At 12 months post randomization |
| Cost per quality-adjusted life year (QALY) gained | Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained. | At 12 months post randomization |
| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |