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Completed

NCT Number: NCT03404596

Applying mHealth to Tobacco-related Health Disparities

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine patch

Drug

Nicotine patches and thorough education of the indications for the patch will be provided to all participants.

Counseling

Behavioral

Brief counseling sessions, 10-15 minutes each.

smartphone

Behavioral

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.

AutoSense

Other

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.

Primary outcomes

  1. Rate of Smoking Lapse

    Time frame: Up to 36 months

    Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).

  2. Rate of Stress

    Time frame: Up to 36 months

    Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: Time2Quit

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2018
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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