This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
6 weeks of nicotine replacement therapy patches
This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment.
The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking).
University of Miami
Miami, Florida, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Number of Participants With Confirmed Smoking Abstinence
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.
Time frame: 3 months
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?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up)
Time frame: Baseline, 3 months
Number of Participants With Reported Relapse
Relapse is defined as smoking at least once/week on two consecutive weeks.
Time frame: 3 months
Usability of the Craving-to-Quit App
How usable participants found the app measured by the absolute number of times logged into the app.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Acceptability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes.
Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes.
Standard advice on how to quit smoking.
Written materials on how to quit smoking including contact info for state tobacco quitline.
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.
Time frame: 3 months
Feasibility of Recruitment as Assessed Via Enrollment Rate
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.
Time frame: Baseline
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.
Time frame: 3 months