Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
Overview
- Phase
- Phase 4
- Intervention
- Nicoderm C-Q Transdermal Product
- Conditions
- Tobacco Smoking
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Number of Participants With Confirmed Smoking Abstinence
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief Summary
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
Investigators
Taghrid Asfar
Research Assistant Professor
University of Miami
Eligibility Criteria
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
Arms & Interventions
Usual Care
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.
Intervention: Nicoderm C-Q Transdermal Product
Usual Care
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.
Intervention: Brief advice on quitting smoking
Usual Care
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.
Intervention: Self-help smoking cessation materials
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.
Intervention: Nicoderm C-Q Transdermal Product
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.
Intervention: Orientation session
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.
Intervention: 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.
Intervention: Two brief follow-up phone calls
Group Mindfulness Training
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).
Intervention: Nicoderm C-Q Transdermal Product
Group Mindfulness Training
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).
Intervention: Orientation session
Group Mindfulness Training
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).
Intervention: Group MT sessions
Outcomes
Primary Outcomes
Number of Participants With Confirmed Smoking Abstinence
Time Frame: 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 Outcomes
- Change in Number of Cigarettes Smoked Per Day(Baseline, 3 months)
- Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use(3 months)
- Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App(3 months)
- Feasibility of Recruitment as Assessed Via Enrollment Rate(Baseline)
- Number of Participants With Reported Relapse(3 months)
- Usability of the Craving-to-Quit App(3 months)
- Acceptability(3 months)
- Attrition(3 months)