Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R00MD010468 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
The purpose of this study is to better understand what happens when someone attempts to quit smoking.
Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. Mobile Health (mHealth) is a general term for the use of mobile phones and other wireless technology in medical care.
The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense. AutoSense is a type of human sensing technology that allows investigators to detect smoking behavior and stress objectively through a chest strap and wrist bands worn by participants. Ecological momentary assessment (EMA) will assess acute precipitants such as negative affect, craving, self-efficacy, motivation, alcohol consumption, etc. Questionnaires will assess other predictors and mechanisms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking Cessation Therapy | Experimental | Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Nicotine patches and thorough education of the indications for the patch will be provided to all participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Smoking Lapse | Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense). | Up to 36 months |
| Rate of Stress | Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense). | Up to 36 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Vinci, Ph.D | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40106803 | Derived | Vinci C, Sutton SK, Yang MJ, Jones SR, Kumar S, Wetter DW. Proximal Effects of a Just-in-Time Adaptive Intervention for Smoking Cessation With Wearable Sensors: Microrandomized Trial. JMIR Mhealth Uhealth. 2025 Mar 19;13:e55379. doi: 10.2196/55379. | |
| 33625366 | Derived | Hernandez LM, Wetter DW, Kumar S, Sutton SK, Vinci C. Smoking Cessation Using Wearable Sensors: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2021 Feb 24;10(2):e22877. doi: 10.2196/22877. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Counseling | Behavioral | Brief counseling sessions, 10-15 minutes each. |
|
| Smartphone | Behavioral | Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. |
|
| AutoSense | Other | Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors. |
|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |