Mindfulness Based Smoking Cessation Among Cancer Survivors

Smartphone Application Versus In-person Mindfulness-based Smoking Cessation Intervention for Young Cancer Survivors: Reach Versus Effectiveness

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

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Brief advice on quitting smoking; Behavioral: Self-help smoking cessation materials; Behavioral: Orientation session; Behavioral: Craving-to-Quit app; Behavioral: Two brief follow-up phone calls; Behavioral: Group MT sessions

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Taghrid Asfar, MD; Phone Number: 305-243-3826; Email: tasfar@miami.edu
• Study Contact Backup: Name: Lily Friedman; Phone Number: 609-647-5800; Email: lxf699@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Lily Friedman, BS; Phone Number: 609-647-5800; Email: lxf699@miami.edu
      • Principal Investigator: Taghrid Asfar, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Tara M Brinkman; Email: tara.brinkman@stjude.org
      • Contact: Ruth Eliason; Email: ruth.eliason@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 using any non-cigarette tobacco products
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Nicoderm C-Q Transdermal Product; 6 weeks of nicotine replacement therapy patches; Behavioral: Brief advice on quitting smoking; Standard advice on how to quit smoking.; Behavioral: Self-help smoking cessation materials; Written materials on how to quit smoking including contact info for state tobacco quitline.
Experimental: Craving-to-Quit app; Participants in this group will receive one in-person orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.	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 written informed consent, and complete the baseline assessment.; Behavioral: 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).; Behavioral: 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.
Experimental: In-person 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).	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 written informed consent, and complete the baseline assessment.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of participants with reported relapse	Relapse is defined as smoking at least once/week on two consecutive weeks.	3 months
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
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
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
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
Feasibility of recruitment as assessed via enrollment rate	A feasible recruitment is defined as an enrollment rate of 70% or higher.	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.	3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Taghrid Asfar, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cancer; mindfulness; nicotine replacement therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20190328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No