Tobacco SmokingPhase 4NCT04038255
Mindfulness Based Smoking Cessation Among Cancer Survivors
A Phase 4 study testing Nicoderm C-Q Transdermal Product, Orientation session and Craving-to-Quit app in people with Tobacco Smoking, run by University of Miami at 2 sites in United States.
Trial summary
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Nicoderm C-Q Transdermal Product, Orientation session and Craving-to-Quit app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2019to 19 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33136
About this study
Official title: Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
- Conditions
- Tobacco Smoking
- Being tested
- Nicoderm C-Q Transdermal Product, Orientation session, Craving-to-Quit app, Two brief follow-up phone calls, Group MT sessions
- Keywords
- cancer, nicotine replacement therapy, mindfulness
- Medical subject headings
- Tobacco Smoking, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm C-Q Transdermal ProductDrug
6 weeks of nicotine replacement therapy patches
Orientation sessionBehavioural
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 appBehavioural
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).
Two brief follow-up phone callsBehavioural
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.
Group MT sessionsBehavioural
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.
Brief advice on quitting smokingBehavioural
Standard advice on how to quit smoking.
Self-help smoking cessation materialsBehavioural
Written materials on how to quit smoking including contact info for state tobacco quitline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Orientation session; Behavioral: Group MT sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (8)
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?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up)
Measured: Baseline, 3 months
Number of Participants With Reported Relapse
Relapse is defined as smoking at least once/week on two consecutive weeks.
Measured: 3 months
Usability of the Craving-to-Quit App
How usable participants found the app measured by the absolute number of times logged into the app.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Feasibility of Recruitment as Assessed Via Enrollment Rate
Percentage of enrolled in each arm out of the 44 that were originally recruited (number recruited divided by number enrolled multiplied by 100). A feasible recruitment is defined as an enrollment rate of 70% or higher.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start28 Sep 2019
- Primary completion19 May 2024
- Study completion19 May 2024
Why it stopped: Recruitment for the study proved to be a significant challenge, raising important concerns about its overall feasibility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid Asfar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038255
- Sponsor's protocol ID
- 20190328
- Status last verified
- Aug 2025
- First submitted
- 26 Jul 2019
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
- ClinicalTrials.gov ID
- NCT04038255
- Acronym / sponsor ID
- 20190328
- Conditions
- Tobacco Smoking
- Keywords
- cancer, nicotine replacement therapy, mindfulness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment for the study proved to be a significant challenge, raising important concerns about its overall feasibility.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Sep 2019 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 19 May 2024 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Brief advice on quitting smoking, Behavioral: Self-help smoking cessation materialsParticipants 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. |
| Craving-to-Quit app | Experimental | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Orientation session, Behavioral: Craving-to-Quit app, Behavioral: Two brief follow-up phone callsParticipants 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. |
| Group Mindfulness Training | Experimental | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Orientation session, Behavioral: Group MT sessionsParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicoderm C-Q Transdermal Product6 weeks of nicotine replacement therapy patches | Drug | Craving-to-Quit app, Group Mindfulness Training, Usual Care |
| Orientation sessionThis 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. | Behavioural | Craving-to-Quit app, Group Mindfulness Training |
| Craving-to-Quit appThe 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). | Behavioural | Craving-to-Quit app |
| Two brief follow-up phone callsThe 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. | Behavioural | Craving-to-Quit app |
| Group MT sessionsTotal 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. | Behavioural | Group Mindfulness Training |
| Brief advice on quitting smokingStandard advice on how to quit smoking. | Behavioural | Usual Care |
| Self-help smoking cessation materialsWritten materials on how to quit smoking including contact info for state tobacco quitline. | Behavioural | Usual Care |
Primary outcome
Number of Participants With Confirmed Smoking Abstinence
Time frame: 3 months
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.
8 secondary outcomes
Change in Number of Cigarettes Smoked Per Day
Time frame: Baseline, 3 months
Number of Participants With Reported Relapse
Time frame: 3 months
Usability of the Craving-to-Quit App
Time frame: 3 months
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Time frame: 3 months
Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App
Time frame: 3 months
Acceptability
Time frame: 3 months
Feasibility of Recruitment as Assessed Via Enrollment Rate
Time frame: Baseline
Attrition
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taghrid Asfar, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicoderm C-Q Transdermal Product, Orientation session and Craving-to-Quit app in people with Tobacco Smoking, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Confirmed Smoking Abstinence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.