Mindfulness Based Smoking Cessation Among Cancer Survivors

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04038255

Collaborator

(none)

Enrollment

Location

Arms

47.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 28, 2019

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Number of participants with confirmed smoking abstinence [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

Change in number of cigarettes smoked per day [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?)
Number of participants with reported relapse [3 months]
Relapse is defined as smoking at least once/week on two consecutive weeks.
Usability of the Craving-to-Quit app as assessed by the number of times participant logged in the app [3 months]
How usable participants found the app measured by the absolute number of times logged into the app.
Usability of the Craving-to-Quit app as assessed by the number of days of completed app use [3 months]
How usable participants found the app measured by self-reported number of completed days for the app.
Usability of the Craving-to-Quit app as assessed by the comfortability with the app [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.
Acceptability [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.
Feasibility of recruitment as assessed via enrollment rate [Baseline]
A feasible recruitment is defined as an enrollment rate of 70% or higher.
Attrition [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Taghrid Asfar, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taghrid Asfar, Research Assistant Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04038255

Other Study ID Numbers:

20190328

First Posted:

Jul 30, 2019

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Taghrid Asfar, Research Assistant Professor, University of Miami

cancer

nicotine replacement therapy

mindfulness

Additional relevant MeSH terms:

Nicotine

Study Results

No Results Posted as of Jun 15, 2022