Mindfulness Based Smoking Cessation Among Cancer Survivors

Phase 4

Terminated

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 20

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

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	Number of participants who 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
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?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up)
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.
Feasibility of Recruitment as Assessed Via Enrollment Rate	Baseline	Percentage of enrolled in each arm out of the 44 that were originally recruited (number recruited divided by number enrolled multiplied by 100). A feasible recruitment is defined as an enrollment rate of 70% or higher.
Number of Participants With Reported Relapse	3 months	Relapse is defined as smoking at least once/week on two consecutive weeks.
Usability of the Craving-to-Quit App	3 months	How usable participants found the app measured by the absolute number of times logged into 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.
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
University of Miami
🇺🇸Miami, Florida, United States