Mindfulness Based Smoking Cessation Among Cancer Survivors

NCT04038255 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20190328
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tobacco Smoking

Keywords

cancer; nicotine replacement therapy; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

• Change in Number of Cigarettes Smoked Per Day

  Baseline, 3 months

• Number of Participants With Reported Relapse

  3 months

• Usability of the Craving-to-Quit App

  3 months

• Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use

  3 months

• Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App

  3 months

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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; Behavioral: Brief advice on quitting smoking; Behavioral: Self-help smoking cessation materials

Craving-to-Quit app

EXPERIMENTAL

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.

Drug: Nicoderm C-Q Transdermal Product; Behavioral: Orientation session; Behavioral: Craving-to-Quit app; Behavioral: Two brief follow-up phone calls

Group Mindfulness Training

EXPERIMENTAL

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; Behavioral: Orientation session; Behavioral: Group MT sessions

Interventions

Nicoderm C-Q Transdermal Product DRUG

6 weeks of nicotine replacement therapy patches

Craving-to-Quit app; Group Mindfulness Training; Usual Care

Orientation session BEHAVIORAL

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; Group Mindfulness Training

Craving-to-Quit app BEHAVIORAL

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).

Craving-to-Quit app

Two brief follow-up phone calls BEHAVIORAL

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.

Craving-to-Quit app

Group MT sessions BEHAVIORAL

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.

Group Mindfulness Training

Brief advice on quitting smoking BEHAVIORAL

Standard advice on how to quit smoking.

Usual Care

Self-help smoking cessation materials BEHAVIORAL

Written materials on how to quit smoking including contact info for state tobacco quitline.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Neoplasms

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Taghrid Asfar
• Organization: University of Miami

tasfar@miami.edu

+1 (901)-371-7229

Study Officials

• Taghrid Asfar, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: September 28, 2019
• Primary Completion: May 19, 2024
• Study Completion: May 19, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)