Mindfulness Based Smoking Cessation Among Cancer Survivors

Phase 4

Completed

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

• Registration Number: NCT04038255
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2019-09-28
• Primary Completion: 2024-05-19
• Study Completion: 2024-05-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Have cognitive/mental health impairment that inhibits mindfulness treatment
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Nicoderm C-Q Transdermal Product	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.
Usual Care	Brief advice on quitting smoking	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.
Craving-to-Quit app	Nicoderm C-Q Transdermal Product	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.
Craving-to-Quit app	Orientation session	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.
Craving-to-Quit app	Craving-to-Quit app	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.
Craving-to-Quit app	Two brief follow-up phone calls	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.
Group Mindfulness Training	Nicoderm C-Q Transdermal Product	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).
Usual Care	Self-help smoking cessation materials	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.
Group Mindfulness Training	Orientation session	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).
Group Mindfulness Training	Group MT sessions	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).

Primary Outcome Measures

Name	Time	Method
Number of participants with confirmed smoking abstinence	3 months	self-report of not smoking in the past 7-days, not even a puff, confirmed by expired carbon monoxide (CO) level of \< 10 ng/ml

Secondary Outcome Measures

Name	Time	Method
Number of participants with reported relapse	3 months	Relapse is defined as smoking at least once/week on two consecutive weeks.
Change in number of cigarettes smoked per day	Baseline, 3 months	Self-reported number of cigarettes smoked per day by each participant (Question is: On average, how many cigarettes do you smoke per day?)
Usability of the Craving-to-Quit app as assessed by the number of times participant logged in the app	3 months	How usable participants found the app measured by the absolute number of times logged into the app.
Usability of the Craving-to-Quit app as assessed by the number of days of completed app use	3 months	How usable participants found the app measured by self-reported number of completed days for the app.
Usability of the Craving-to-Quit app as assessed by the comfortability with the app	3 months	How usable participants found the app measured by the comfortability of the app via questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with the app.
Acceptability	3 months	Assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.
Feasibility of recruitment as assessed via enrollment rate	Baseline	A feasible recruitment is defined as an enrollment rate of 70% or higher.
Attrition	3 months	Defined as the number of participants not having a final visit at the end of treatment, categories include mortality, withdrawal from the study, transfer to non-study clinics, loss to follow-up without identifiable cause.

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Miami, Florida, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States