Trial Outcomes & Findings for Mindfulness Based Smoking Cessation Among Cancer Survivors (NCT NCT04038255)
NCT ID: NCT04038255
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2025-09-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
11
|
9
|
|
Overall Study
COMPLETED
|
0
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
9
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
Baseline characteristics by cohort
| Measure |
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.
|
Craving-to-Quit App
n=11 Participants
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.
|
Group Mindfulness Training
n=9 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
—
|
59.40 years
STANDARD_DEVIATION 15.04 • n=11 Participants
|
64.71 years
STANDARD_DEVIATION 6.21 • n=9 Participants
|
61.56 years
STANDARD_DEVIATION 11.84 • n=20 Participants
|
|
Sex: Female, Male
Female
|
—
|
7 Participants
n=10 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
3 Participants
n=7 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
10 Participants
n=17 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
|
Sex: Female, Male
Male
|
—
|
3 Participants
n=10 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
4 Participants
n=7 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
7 Participants
n=17 Participants • There were 3 participants that were randomized to a group, but did not complete a baseline; thus we can't verify their gender.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
8 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
—
|
6 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
9 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
—
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
—
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian/Asian American/Pacific Islander
|
—
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
—
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
—
|
1 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Due to difficulties in enrollment, we could not recruit participants for usual care arm.
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.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=11 Participants
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.
|
Group Mindfulness Training
n=9 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Confirmed Smoking Abstinence
Self-reported quitting
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Confirmed Smoking Abstinence
self-report of quitting confirmed by CO < 10 ng/ml
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Due to difficulties in recruitment, no one was added to Usual Care Arm.
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)
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=11 Participants
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.
|
Group Mindfulness Training
n=9 Participants
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.
|
|---|---|---|---|
|
Change in Number of Cigarettes Smoked Per Day
|
—
|
0 change in cigarettes/day
Standard Deviation 0
|
3 change in cigarettes/day
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Due to difficulties in recruitment, we were not able to recruit participants for the Usual Care Arm.
Relapse is defined as smoking at least once/week on two consecutive weeks.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=11 Participants
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.
|
Group Mindfulness Training
n=9 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Reported Relapse
|
—
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only 2 people from the Craving to Quit App arm answered for the 3-month follow-up.
How usable participants found the app measured by the absolute number of times logged into the app.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=2 Participants
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.
|
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.
|
|---|---|---|---|
|
Usability of the Craving-to-Quit App
Not often
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Usability of the Craving-to-Quit App
Everyday
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Usability of the Craving-to-Quit App
Often
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Usability of the Craving-to-Quit App
Some days
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Usability of the Craving-to-Quit App
Not at all
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
How usable participants found the app measured by self-reported number of completed days for the app.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=2 Participants
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.
|
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.
|
|---|---|---|---|
|
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Every day
|
—
|
0 Participants
|
—
|
|
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Often
|
—
|
0 Participants
|
—
|
|
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Some days
|
—
|
2 Participants
|
—
|
|
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Not often
|
—
|
0 Participants
|
—
|
|
Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use
Not at all
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Number of participants from this treatment arm who responded to the 3-month follow-up.
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.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=2 Participants
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.
|
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.
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|---|---|---|---|
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Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App
|
—
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10 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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).
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.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=2 Participants
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.
|
Group Mindfulness Training
n=3 Participants
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.
|
|---|---|---|---|
|
Acceptability
How satisfied were you with the intervention?
|
—
|
7.5 score on a scale
Standard Deviation 0.71
|
9 score on a scale
Standard Deviation 1.73
|
|
Acceptability
How likely are you to recommend this intervention to a friend?
|
—
|
10 score on a scale
Standard Deviation 0
|
10 score on a scale
Standard Deviation 0
|
|
Acceptability
How useful was the intervention
|
—
|
10 score on a scale
Standard Deviation 1.41
|
10 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.
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.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=44 Participants
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.
|
Group Mindfulness Training
n=44 Participants
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.
|
|---|---|---|---|
|
Feasibility of Recruitment as Assessed Via Enrollment Rate
|
—
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Study was closed to enrollment due to difficulty in participant recruitment before we started enrolling to the Usual Care Arm.
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.
Outcome measures
| Measure |
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.
|
Craving-to-Quit App
n=11 Participants
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.
|
Group Mindfulness Training
n=9 Participants
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.
|
|---|---|---|---|
|
Attrition
Loss to follow-up without identifiable cause
|
—
|
9 participants
|
5 participants
|
|
Attrition
Mortality
|
—
|
0 participants
|
0 participants
|
|
Attrition
Withdrawal
|
—
|
0 participants
|
1 participants
|
|
Attrition
Transfer to non-study clinic
|
—
|
0 participants
|
0 participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Craving-to-Quit App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Mindfulness Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place