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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA293229 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Fred Hutchinson Cancer Center | OTHER |
| University of California, Davis | OTHER |
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The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking.
The investigators hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months.
The investigators also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Intervention | Active Comparator | Control participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. |
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| Experimental | Experimental | Experimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Intervention | Behavioral | GEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence-based treatment request | Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. | 6-months post-randomization |
| 7-day Point Prevalence Abstinence (PPA) [Self-report] | Self-report of no smoking, even a puff, in the past 7 days. | 6-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Abstinence (PPA) [Self-report] | Self-report of no smoking, even a puff, in the past 7 days. (Co-primary outcome assessed at earlier time point) | 3-months post-randomization |
| 30-day Point Prevalence Abstinence (PPA) [Self-report] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer B McClure, PhD | Contact | 503-335-2400 | jennifer.b.mcclure@kp.org | |
| Anna C Edelmann, MScN | Contact | 866-459-2816 | anna.c.edelmann@kpchr.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Center for Health Research | Recruiting | Portland | Oregon | 97227 | United States |
Deidentified data and accompanying data dictionaries will be stored for future sharing as anonymized data sets in a data repository per NIH data sharing requirements.
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Randomized controlled trial
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| Experimental Intervention | Behavioral | GEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration. |
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Self-report of no smoking, even a puff, in the past 30 days. |
| 3- and 6-months post-randomization |
| 7-day Point Prevalence Abstinence (PPA) [Confirmed] | Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days. | 6-months post-randomization |
| Evidence-based treatment request | Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. (Co-primary outcome assessed at earlier time point). | 3-months post-randomization |
| Use of any cessation treatment | Self-reported use of any evidence-based smoking cessation treatment (FDA-approved medication or behavioral interventions) since enrollment, whether provided by study or not. | 3- and 6-months post-randomization |
| Successful 24-hour quit attempt | Self-reported presence of an intentional quit attempt lasting at least 24 hrs (Y/N) since randomization. | By 3-months and 6-months post-randomization |
| Any quit attempt | Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment. | By 3-months and 6-months post-randomization |
| Change in cigarettes per day | Change from baseline in number of cigarettes smoked per day at follow-up, calculated both as a continuous measure and as a dichotomous measure (Y/N >=50% reduction from baseline). | Baseline to each of 3-months and 6-months post-randomization |
| Tobacco and nicotine abstinence | Self-report of abstinence from all non-therapeutic nicotine and tobacco products. | 3- and 6-months post-randomization |