Mindfulness Based Smoking Cessation Among Cancer Survivors
NCT ID: NCT04038255
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
20 participants
INTERVENTIONAL
2019-09-28
2024-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Nicoderm C-Q Transdermal Product
6 weeks of nicotine replacement therapy patches
Brief advice on quitting smoking
Standard advice on how to quit smoking.
Self-help smoking cessation materials
Written materials on how to quit smoking including contact info for state tobacco quitline.
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.
Nicoderm C-Q Transdermal Product
6 weeks of nicotine replacement therapy patches
Orientation session
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.
Craving-to-Quit app
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).
Two brief follow-up phone calls
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.
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).
Nicoderm C-Q Transdermal Product
6 weeks of nicotine replacement therapy patches
Orientation session
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.
Group MT sessions
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.
Interventions
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Nicoderm C-Q Transdermal Product
6 weeks of nicotine replacement therapy patches
Orientation session
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.
Craving-to-Quit app
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).
Two brief follow-up phone calls
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.
Group MT sessions
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.
Brief advice on quitting smoking
Standard advice on how to quit smoking.
Self-help smoking cessation materials
Written materials on how to quit smoking including contact info for state tobacco quitline.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Taghrid Asfar
Research Assistant Professor
Principal Investigators
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Taghrid Asfar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20190328
Identifier Type: -
Identifier Source: org_study_id
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