Applying mHealth to Tobacco-related Health Disparities (Time2Quit)

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine Patch; Behavioral: Counseling; Behavioral: Smartphone; Other: AutoSense

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: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

1

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Christine Vinci, Ph.D, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General Publications

• 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.

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; mindfulness; quit smoking; mHealth; nicotine; cigarettes
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• 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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No