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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01983 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.
Objectives:
We propose to develop a mobile smoking intervention termed COmpliance-facilitated Scheduled Smoking Reduction (COSSR) delivered as a smartphone app. Through the proposed research as a pilot study, we want to identify the effect size of the proposed COSSR
intervention. We will pursue the following aims:
Aim 1:
Develop the COSSR app and evaluate the app's usability. In this aim, our first objective is to develop the COSSR app, and our second objective is to evaluate the app's usability, making sure that our app's core features are working, such as generating personalized smoking schedules, recording smoking, and taking carbon monoxide (CO) measures using the portable CO devices. We will recruit 15 participants from across the state of Texas to test our app for 4 weeks.
Aim 2:
Evaluate COSSR's preliminary effects on smoking cessation. In this aim, we will recruit participants (n=60) remotely from across the entire state of Texas to evaluate COSSR's effects on smoking cessation. Participants will be randomly assigned to either the control or the COSSR group. Both groups include the usual care treatment (self-help material and nicotine patches). In the COSSR group, they will use the app to reduce their smoking before quitting, and use 3-week pre-cessation nicotine patches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption |
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| Part 2 | Experimental | Participants will also use the app for the duration of the study (about 3 months). Participants will be asked to record your smoking using the app and complete online surveys |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Phone App | Behavioral | Collection of data |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Application (App) Usability Questionnaire | Scale Scores (1-5) 1-strongly disagree, 2-disagree, 3-neither disagree nor agree, 4-agree and 5-strongly agree | through completion of study; an average of 1 year. |
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Inclusion Criteria:
Age: 18 years old or older
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Cui, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2024 | Feb 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| NIcotine Patches |
| Other |
Place on the skin |
|