H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
NCT Number: NCT03404596
The purpose of this study is to better understand what happens when someone attempts to quit smoking.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Tampa, Florida, 33612, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nicotine patches and thorough education of the indications for the patch will be provided to all participants.
Brief counseling sessions, 10-15 minutes each.
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.
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.
Time frame: Up to 36 months
Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).
Time frame: Up to 36 months
Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).
H. Lee Moffitt Cancer Center and Research Institute
Other
Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)
Acronym: Time2Quit
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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