- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404596
Applying mHealth to Tobacco-related Health Disparities (Time2Quit)
Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Smoked a minimum of 3 cigarettes per day over the past year
- Expired carbon monoxide reading ≥ 6
- Motivated to quit within the next 30 days
- Valid home address
- Functioning telephone number
- Can speak, read, and write in English
- At least marginal health literacy
Exclusion Criteria:
- Contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided
- Endorse current psychosis
- Have a pacemaker or implanted device
- Physically unable to wear equipment and provide a good reading of physiological measures
- Current use of tobacco cessation medications
- Current use of of smoking products other than cigarettes and e-cigarettes
- Involvement in a smoking program or currently trying to quit
- Pregnancy or lactation
- Another household member being enrolled in the study
- No prior experience with a smart phone
- The study staff or principal investigator (PI) have serious concerns about the participant's ability to engage in and/or complete the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smoking Cessation Therapy
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Smoking Lapse
Time Frame: Up to 36 months
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Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).
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Up to 36 months
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Rate of Stress
Time Frame: Up to 36 months
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Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).
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Up to 36 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Christine Vinci, Ph.D, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-19002
- R00MD010468 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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