Tobacco Smoking Clinical Trial
Official title:
Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with confirmed smoking abstinence | 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 | 3 months | |
Secondary | Change in number of cigarettes smoked per day | Self-reported number of cigarettes smoked per day by each participant (Question is: On average, how many cigarettes do you smoke per day?) | Baseline, 3 months | |
Secondary | Number of participants with reported relapse | Relapse is defined as smoking at least once/week on two consecutive weeks. | 3 months | |
Secondary | Usability of the Craving-to-Quit app as assessed by the number of times participant logged in the app | How usable participants found the app measured by the absolute number of times logged into the app. | 3 months | |
Secondary | Usability of the Craving-to-Quit app as assessed by the number of days of completed app use | How usable participants found the app measured by self-reported number of completed days for the app. | 3 months | |
Secondary | Usability of the Craving-to-Quit app as assessed by the comfortability with the app | 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. | 3 months | |
Secondary | Acceptability | 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. | 3 months | |
Secondary | Feasibility of recruitment as assessed via enrollment rate | A feasible recruitment is defined as an enrollment rate of 70% or higher. | Baseline | |
Secondary | Attrition | 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. | 3 months |
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