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Mindfulness-Based Smoking Cessation for Smoking

Phase 4
Recruiting
Led By Taghrid Asfar, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 1 day
Treatment 1 months
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test whether a mindfulness-based smoking cessation program can help cancer survivors quit smoking.

Who is the study for?
This trial is for young adult cancer survivors aged 18-40 who smoke at least 5 cigarettes a day and are interested in quitting within the next month. Participants must own a smartphone, not be pregnant or planning pregnancy soon, and have no plans to move shortly. Those with cognitive impairments, current smoking cessation treatment, or substance abuse issues cannot join.Check my eligibility
What is being tested?
The study tests a mindfulness-based program to help stop smoking. It includes an orientation session, group Mindfulness Training (MT) sessions, two follow-up calls, use of the Craving-to-Quit app and Nicoderm C-Q patches for nicotine replacement therapy along with brief advice and self-help materials.See study design
What are the potential side effects?
Possible side effects may include skin irritation from the nicotine patch and typical challenges related to quitting smoking such as increased appetite, mood swings, irritability, difficulty concentrating and cravings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.
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I have been diagnosed with cancer at some point in my life.
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You have smoked at least 5 cigarettes per day in the last year.
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You have an Apple or Android smartphone.

Timeline

Screening ~ 1 day
Treatment ~ 1 months
Follow Up ~3 months
This trial's timeline: 1 day for screening, 1 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with confirmed smoking abstinence
Secondary outcome measures
Acceptability
Attrition
Change in number of cigarettes smoked per day
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: In-person Mindfulness TrainingExperimental Treatment3 Interventions
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).
Group II: Craving-to-Quit appExperimental Treatment4 Interventions
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.
Group III: Usual CareActive Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicoderm C-Q Transdermal Product
2019
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
902 Previous Clinical Trials
410,016 Total Patients Enrolled
Taghrid Asfar, MDPrincipal Investigator - University of Miami
University of Miami
3 Previous Clinical Trials
781 Total Patients Enrolled

Media Library

Group MT sessions Clinical Trial Eligibility Overview. Trial Name: NCT04038255 — Phase 4
Tobacco Smoking Research Study Groups: Usual Care, In-person Mindfulness Training, Craving-to-Quit app
Tobacco Smoking Clinical Trial 2023: Group MT sessions Highlights & Side Effects. Trial Name: NCT04038255 — Phase 4
Group MT sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038255 — Phase 4
Tobacco Smoking Patient Testimony for trial: Trial Name: NCT04038255 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for joining this clinical research study?

"In this trial, 60 individuals aged between 18 and 40 who have engaged in tobacco use within the past year are being accepted. To qualify for recruitment, participants must also fulfil the following criteria: Be a young cancer survivor; Smoke at least 5 cigarettes daily; Contemplate quitting smoking during the upcoming 30 days; Possess an Apple or Android phone; Have capacity to provide informed consent; Remain stationary over 3 months time-frame; Not be pregnant or expecting pregnancy in three months’ period."

Answered by AI

What is the current capacity of this research endeavor?

"Affirmative. According to the clinicaltrials.gov records, this research trial is actively enrolling participants; it was first posted on September 28th 2019 and last updated in October 26th 2022. Currently they are looking for 60 volunteers from 2 different locations."

Answered by AI

Is the FDA sanctioning Group MT sessions as a medical treatment?

"There is ample evidence to confirm the safety of Group MT sessions, thus its rating was 3. This therapy has already been approved by medical authorities and a Phase 4 trial is being conducted."

Answered by AI

Is this investigation accepting individuals aged fifty and beyond?

"To partake in this medical study, patients must be between the prime ages of 18 and 40. In addition to this trial there are 8 more for those below 18 years old and 86 extra trials designed for seniors over 65."

Answered by AI

Has there been any research on the efficacy of Group MT sessions previously?

"First researched in 2006 at The University of Hong Kong, group MT sessions have seen the completion of 396 studies. At present, 71 are actively ongoing; notably many are being administered from Miami, Florida."

Answered by AI

Are there any openings to join this clinical experiment?

"Confirmed, clinicaltrials.gov states that this research trial is in the process of finding participants to enrol. It was first published on September 28th 2019 and last modified October 26th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
Tennessee
Florida
How old are they?
18 - 65
What site did they apply to?
St. Jude Children's Research Hospital
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

I want to quit. NRT was not enough. I want to quit smoking. I wants STOP SMOKING!!!!!
PatientReceived 2+ prior treatments
I have a need to quit smoking.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Mindfulness Based Smoking Cessation Among Cancer Survivors
Taghrid Asfar 2019. "Mindfulness Based Smoking Cessation Among Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038255.
All > Mindfulness > Smoking Cessation
~4 spots leftby Sep 2024
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