NCT03404596

Applying mHealth to Tobacco-related Health Disparities

Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine Patch	Nicotine patches and thorough education of the indications for the patch will be provided to all participants.
BEHAVIORAL	Counseling	Brief counseling sessions, 10-15 minutes each.
BEHAVIORAL	Smartphone	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.
OTHER	AutoSense	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.

Timeline

• Start date: 2018-07-16
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2018-01-19
• Last updated: 2023-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study