Clinical trial NCT03404596: Applying mHealth to Tobacco-related Health Disparities
Official title: Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Keywords: cigarettes
quit smoking
nicotine
mindfulness
mHealth
mobile health
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to better understand what happens when someone attempts to quit smoking.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Smoking Lapse
timeFrame: Up to 36 months
measure: Rate of Stress
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Christine Vinci, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.