Applying mHealth to Tobacco-related Health Disparities (Time2Quit)

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Early Phase 1

Conditions: Smoking Cessation

Treatments: Behavioral: Smartphone; Other: AutoSense; Drug: Nicotine Patch; Behavioral: Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03404596

R00MD010468 (U.S. NIH Grant/Contract)

MCC-19002

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Smoking Cessation Therapy

Experimental group

Description:

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.

Treatment:

Other: AutoSense

Behavioral: Counseling

Drug: Nicotine Patch

Behavioral: Smartphone