Applying mHealth to Tobacco-related Health Disparities

Smoking Cessation Clinical Trial

— Time2Quit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404596
• Other study ID #: MCC-19002
• Secondary ID: R00MD010468
• Status: Completed
• Phase: Early Phase 1
• Start date: July 16, 2018
• Est. completion date: December 14, 2020

Study information

• Verified date: May 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Smoking Lapse	Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense).	Up to 36 months
Primary	Rate of Stress	Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense).	Up to 36 months

External Links

•   Moffitt Cancer Center Clinical Trials website