Tobacco Smoking
Conditions
Keywords
cancer, nicotine replacement therapy, mindfulness
Brief summary
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
Interventions
6 weeks of nicotine replacement therapy patches
BEHAVIORALOrientation 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 electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment.
BEHAVIORALCraving-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).
BEHAVIORALTwo 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.
BEHAVIORALGroup 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.
BEHAVIORALBrief advice on quitting smoking
Standard advice on how to quit smoking.
BEHAVIORALSelf-help smoking cessation materials
Written materials on how to quit smoking including contact info for state tobacco quitline.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Smoking Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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?. Calculated as # of cigarettes reported at Baseline minus # of cigarettes reported at 3-month follow-up) |
| 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 | 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 | 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The Usual Care Arm was the arm of the intervention where participants would receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy, and self-help materials to quit smoking. Unfortunately, the study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm, which would occur after sufficient enrollment in the mindfulness training arm. As a result, no participants were enrolled in the Usual Care Arm.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches
Brief advice on quitting smoking: Standard advice on how to quit smoking.
Self-help smoking cessation materials: Written materials on how to quit smoking including contact info for state tobacco quitline. | 0 |
| Craving-to-Quit App 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.
Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches
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 electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment.
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).
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. | 11 |
| Group 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).
Nicoderm C-Q Transdermal Product: 6 weeks of nicotine replacement therapy patches
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 electronic informed consent which will be audio-recorded with their permission, and complete the baseline assessment.
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. | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 9 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Craving-to-Quit App | Total | Group Mindfulness Training |
|---|---|---|---|
| Age, Continuous | 59.40 years STANDARD_DEVIATION 15.04 | 61.56 years STANDARD_DEVIATION 11.84 | 64.71 years STANDARD_DEVIATION 6.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian/Asian American/Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 0 | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 0 | 0 / 11 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 3 months
Population: Due to difficulties in enrollment, we could not recruit participants for usual care arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Confirmed Smoking Abstinence | Self-reported quitting | 0 Participants |
| Usual Care | Number of Participants With Confirmed Smoking Abstinence | self-report of quitting confirmed by CO < 10 ng/ml | 0 Participants |
| Craving-to-Quit App | Number of Participants With Confirmed Smoking Abstinence | Self-reported quitting | 2 Participants |
| Craving-to-Quit App | Number of Participants With Confirmed Smoking Abstinence | self-report of quitting confirmed by CO < 10 ng/ml | 1 Participants |
| Group Mindfulness Training | Number of Participants With Confirmed Smoking Abstinence | Self-reported quitting | 0 Participants |
| Group Mindfulness Training | Number of Participants With Confirmed Smoking Abstinence | self-report of quitting confirmed by CO < 10 ng/ml | 0 Participants |
Secondary
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.
Time frame: 3 months
Population: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm. Only 5 people answered the 3 month follow-up for their corresponding groups (2 for Craving to Quit, 3 for Group Mindfulness Training).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Craving-to-Quit App | Acceptability | How satisfied were you with the intervention? | 7.5 score on a scale | Standard Deviation 0.71 |
| Craving-to-Quit App | Acceptability | How likely are you to recommend this intervention to a friend? | 10 score on a scale | Standard Deviation 0 |
| Craving-to-Quit App | Acceptability | How useful was the intervention | 10 score on a scale | Standard Deviation 1.41 |
| Group Mindfulness Training | Acceptability | How satisfied were you with the intervention? | 9 score on a scale | Standard Deviation 1.73 |
| Group Mindfulness Training | Acceptability | How likely are you to recommend this intervention to a friend? | 10 score on a scale | Standard Deviation 0 |
| Group Mindfulness Training | Acceptability | How useful was the intervention | 10 score on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 3 months
Population: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Craving-to-Quit App | Attrition | Loss to follow-up without identifiable cause | 9 participants |
| Craving-to-Quit App | Attrition | Mortality | 0 participants |
| Craving-to-Quit App | Attrition | Withdrawal | 0 participants |
| Craving-to-Quit App | Attrition | Transfer to non-study clinic | 0 participants |
| Group Mindfulness Training | Attrition | Transfer to non-study clinic | 0 participants |
| Group Mindfulness Training | Attrition | Loss to follow-up without identifiable cause | 5 participants |
| Group Mindfulness Training | Attrition | Withdrawal | 1 participants |
| Group Mindfulness Training | Attrition | Mortality | 0 participants |
Secondary
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)
Time frame: Baseline, 3 months
Population: Due to difficulties in recruitment, no one was added to Usual Care Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Craving-to-Quit App | Change in Number of Cigarettes Smoked Per Day | 0 change in cigarettes/day | Standard Deviation 0 |
| Group Mindfulness Training | Change in Number of Cigarettes Smoked Per Day | 3 change in cigarettes/day | Standard Deviation 7.55 |
Secondary
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.
Time frame: Baseline
Population: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Craving-to-Quit App | Feasibility of Recruitment as Assessed Via Enrollment Rate | 11 Participants |
| Group Mindfulness Training | Feasibility of Recruitment as Assessed Via Enrollment Rate | 9 Participants |
Secondary
Number of Participants With Reported Relapse
Relapse is defined as smoking at least once/week on two consecutive weeks.
Time frame: 3 months
Population: Due to difficulties in recruitment, we were not able to recruit participants for the Usual Care Arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Craving-to-Quit App | Number of Participants With Reported Relapse | 9 Participants |
| Group Mindfulness Training | Number of Participants With Reported Relapse | 9 Participants |
Secondary
Usability of the Craving-to-Quit App
How usable participants found the app measured by the absolute number of times logged into the app.
Time frame: 3 months
Population: Only 2 people from the Craving to Quit App arm answered for the 3-month follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Usability of the Craving-to-Quit App | Not at all | 0 Participants |
| Usual Care | Usability of the Craving-to-Quit App | Often | 0 Participants |
| Usual Care | Usability of the Craving-to-Quit App | Not often | 0 Participants |
| Usual Care | Usability of the Craving-to-Quit App | Everyday | 0 Participants |
| Usual Care | Usability of the Craving-to-Quit App | Some days | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App | Everyday | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App | Not at all | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App | Not often | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App | Often | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App | Some days | 2 Participants |
| Group Mindfulness Training | Usability of the Craving-to-Quit App | Not at all | 0 Participants |
| Group Mindfulness Training | Usability of the Craving-to-Quit App | Some days | 0 Participants |
| Group Mindfulness Training | Usability of the Craving-to-Quit App | Often | 0 Participants |
| Group Mindfulness Training | Usability of the Craving-to-Quit App | Not often | 0 Participants |
| Group Mindfulness Training | Usability of the Craving-to-Quit App | Everyday | 0 Participants |
Secondary
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.
Time frame: 3 months
Population: Number of participants from this treatment arm who responded to the 3-month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App | 10 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 3 months
Population: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.We did not have enough people from the Craving-to-Quit arm do the 3-month follow-up to collect or analyze this data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | Every day | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | Often | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | Some days | 2 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | Not often | 0 Participants |
| Craving-to-Quit App | Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use | Not at all | 0 Participants |