Mindfulness Based Smoking Cessation Among Cancer Survivors

Tobacco Smoking Clinical Trial

Official title:

Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038255
• Other study ID #: 20190328
• Status: Recruiting
• Phase: Phase 4
• Start date: September 28, 2019
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Taghrid Asfar, MD
• Phone: 305-243-3826
• Email: tasfar[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Drug:
• Nicoderm C-Q Transdermal Product
6 weeks of nicotine replacement therapy patches

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

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