Applying mHealth to Tobacco-related Health Disparities

NCT03404596 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: MCC-19002R00MD010468
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Keywords

cigarettes; quit smoking; nicotine; mindfulness; mHealth; mobile health

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Smoking Cessation Therapy

EXPERIMENTAL

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; Behavioral: Counseling; Behavioral: Smartphone; Other: AutoSense

Interventions

Nicotine Patch DRUG

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

Smoking Cessation Therapy

Counseling BEHAVIORAL

Brief counseling sessions, 10-15 minutes each.

Smoking Cessation Therapy

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.

Smoking Cessation Therapy

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.

Smoking Cessation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• Vinci C, Sutton SK, Yang MJ, Jones SR, Kumar S, Wetter DW. Proximal Effects of a Just-in-Time Adaptive Intervention for Smoking Cessation With Wearable Sensors: Microrandomized Trial. JMIR Mhealth Uhealth. 2025 Mar 19;13:e55379. doi: 10.2196/55379.

  PMID: 40106803 DERIVED

• 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.

  PMID: 33625366 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christine Vinci, Ph.D

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: July 16, 2018
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

US (1)