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Mindfulness Based Smoking Cessation Among Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038255
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Taghrid Asfar, University of Miami

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

Condition or disease Intervention/treatment Phase
Tobacco Smoking Drug: Nicoderm C-Q Transdermal Product Behavioral: Orientation session Behavioral: Craving-to-Quit app Behavioral: Two brief follow-up phone calls Behavioral: Group MT sessions Behavioral: Brief advice on quitting smoking Behavioral: Self-help smoking cessation materials Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Application Versus In-person Mindfulness-based Smoking Cessation Intervention for Young Cancer Survivors: Reach Versus Effectiveness
Actual Study Start Date : September 28, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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).
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.




Primary Outcome Measures :
  1. Number of participants with confirmed smoking abstinence [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Change in number of cigarettes smoked per day [ Time Frame: Baseline, 3 months ]
    Self-reported number of cigarettes smoked per day by each participant (Question is: On average, how many cigarettes do you smoke per day?)

  2. Number of participants with reported relapse [ Time Frame: 3 months ]
    Relapse is defined as smoking at least once/week on two consecutive weeks.

  3. Usability of the Craving-to-Quit app as assessed by the number of times participant logged in the app [ Time Frame: 3 months ]
    How usable participants found the app measured by the absolute number of times logged into the app.

  4. Usability of the Craving-to-Quit app as assessed by the number of days of completed app use [ Time Frame: 3 months ]
    How usable participants found the app measured by self-reported number of completed days for the app.

  5. Usability of the Craving-to-Quit app as assessed by the comfortability with the app [ Time Frame: 3 months ]
    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.

  6. Acceptability [ Time Frame: 3 months ]
    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.

  7. Feasibility of recruitment as assessed via enrollment rate [ Time Frame: Baseline ]
    A feasible recruitment is defined as an enrollment rate of 70% or higher.

  8. Attrition [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18-40 years old (young cancer survivors)
  • 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)52
  • 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 in active cancer 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038255


Contacts
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Contact: Taghrid Asfar, MD 305-243-3826 tasfar@miami.edu
Contact: Laura McClure 518-584-8391 lmcclure@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Laura A McClure, MSPH    518-584-8391    lmcclure@med.miami.edu   
Principal Investigator: Taghrid Asfar, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Taghrid Asfar, MD University of Miami
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Responsible Party: Taghrid Asfar, Research Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04038255    
Other Study ID Numbers: 20190328
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Taghrid Asfar, University of Miami:
cancer
nicotine replacement therapy
mindfulness
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action