Mindfulness Based Smoking Cessation Among Cancer Survivors

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Tobacco Smoking

Treatments: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Group MT sessions; Behavioral: Brief advice on quitting smoking; Behavioral: Orientation session; Behavioral: Self-help smoking cessation materials; Behavioral: Craving-to-Quit app; Behavioral: Two brief follow-up phone calls

Study type: Interventional

Funder types: Other

Identifiers

NCT04038255

20190328

Details and patient eligibility

About

This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years and older
• Cancer survivors (based on the NCI definition - "a person is considered to be a survivor from the time of diagnosis until the end of life" National Cancer Institute Dictionary of Cancer Terms, 2014)
• Cancer patients currently in active treatment
• Have smoked ≥ 5 cigarettes/day in the past year
• Be interested in making a quit attempt in the next 30 days
• Own a smartphone (apple/android)
• Read/speak English
• Able to consent
• Have no plans to move in the next 3 months
• Are not pregnant or planning to be pregnant in the following 3 months

Exclusion criteria

• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Are currently being treated for a psychiatric condition
• Are currently being treated for smoking cessation, alcoholism, or illicit drug use
• Are adults unable to consent
• Are individuals who are not yet adults
• Are pregnant women
• Are prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Usual Care

Active Comparator group

Description:

Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking.

Treatment:

Behavioral: Self-help smoking cessation materials

Behavioral: Brief advice on quitting smoking

Drug: Nicoderm C-Q Transdermal Product

Craving-to-Quit app

Experimental group

Description:

Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.

Treatment:

Behavioral: Two brief follow-up phone calls

Behavioral: Craving-to-Quit app

Behavioral: Orientation session

Drug: Nicoderm C-Q Transdermal Product

Group Mindfulness Training

Experimental group

Description:

Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with \>4 years of training in MT).

Treatment:

Behavioral: Orientation session

Behavioral: Group MT sessions

Drug: Nicoderm C-Q Transdermal Product