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| ID | Type | Description | Link |
|---|---|---|---|
| K99CA271040 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.
The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usability Testing | Experimental | Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMI | Device | Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | Percentage of participants who downloaded the study's smartphone application and attended the first counseling session. | At 4 weeks |
| Likability of Mindfulness Practices | Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like). | At 4 weeks |
| Utility of Mindfulness Practices | Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful). | At 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Vinci, PhD | Moffitt Cancer Center | Principal Investigator |
| Min-Jeong Yang, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41809575 | Derived | Yang MJ, Sutton SK, Cottrell-Daniels C, Ritterband LM, Blackwell R, Maconi ML, Poudel R, Pabbathi S, Simmons VN, Vinci C. Mindfulness-based ecological momentary intervention for smoking cessation to address cancer-related relapse risk factors: Intervention development and usability findings. Mindfulness (N Y). 2026 Mar 9. doi: 10.1007/s12671-026-02775-0. Online ahead of print. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usability Testing | Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. EMI: Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usability Testing | Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. EMI: Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Retention Rate | Percentage of participants who downloaded the study's smartphone application and attended the first counseling session. | Posted | Number | percentage of Participants | At 4 weeks |
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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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 | Usability Testing | Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. EMI: Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Vinci | Moffitt Cancer Center | 813-745-5421 | Christine.Vinci@moffitt.org |
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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 | May 2, 2024 | Jun 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Likability of Mindfulness Practices | Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like). | Posted | Median | Full Range | score on a scale | At 4 weeks |
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| Primary | Utility of Mindfulness Practices | Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful). | Posted | Median | Full Range | score on a scale | At 4 weeks |
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