Smoking Cessation
Conditions
Keywords
mHealth, Smoking cessation,
Brief summary
Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively untapped in research available information. This project offers these smokers point-of-need technology support in the many components of the intervention..
Detailed description
The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will have a greater number of days abstinent during the 'break' period, a greater increase in self-efficacy at the end of the 'break' period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This research study will also provide valuable insight into this population of smokers and increase our understanding of which tools may be effective in helping them quit smoking Our Specific Aims are * AIM 1: Refine the Take a Break mHealth tool and implementation program. * AIM 2: Conduct a randomized trial of the effectiveness of Take a Break. * AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation.
Interventions
BEHAVIORALTake a Break as an augmentation to NRT-sampling in Motivation Phase
NRT sampling experience & Suite of mHealth motivational tools and mini-games.
BEHAVIORALNRT and mHealth assessment tool without feedback
NRT and mHealth assessment tool without feedback
Sponsors
National Cancer Institute (NCI)
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For all Aims, investigators will include individuals 18 years and older who are identified as current smokers who are not preparing to quit, and are active in care within the UMMHC system, Northwell Health in Long Island, NY, Reliant Medical Group (RMG) in Worcester, MA and Central Western Massachusetts VA (VACWM) in Worcester, MA. Active in care is defined as having at least two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will be provided to them, free of charge, for the duration of their participation in the study.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Quit Attempt | 6 months | Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy at the End of the 6 Months | 6 months | Self Efficacy is measured by the Self-Efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item instrument (two six-item subscales) that measures the confidence in ability to refrain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers). The scale varies from 1-5 \[Not at all (1) Not very(2) Moderately(3) Very (4) Extremely (5)\] A higher score indicates a higher level of confidence to refrain from smoking in certain social or emotional situations and a lower score indicates a lower level of confidence to refrain from smoking. |
| Point Prevalent Cessation as Measured by Carbon Monoxide Levels | 6 months | Point prevalent cessation here is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood. |
| Mean Number of Days Abstinent During the First 3 Weeks | 3 Weeks | Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment. |
| Number of Participants Abstinent During the First 3 Weeks | 3 Weeks | Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment. . |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal. | 1 week | Participants in the Intervention group were asked to participate in a goal-setting call to establish a smoking abstinence goal (typically one to two days of abstinence from cigarettes). The outcome measures the number of participants who completed to goal-setting call. |
| Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings. | 3 week | TAB participants were encouraged to use mHealth apps that provide relaxation or distraction to help manage smoking cravings. The study team measured the number of participants used mHealth apps to manage nicotine cravings in a 3 week period. |
| Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist) | 2 week | At one week TAB participants were asked to whether they would like to set an abstinence goal for the following 2-week challenge. The outcome measures the number of participants in the TAB group who set a brief abstinence goal |
| Number of Participants Completing Daily Challenge Quiz | 3 weeks | Participants were asked to complete daily challenge quizzes during the first 3 weeks of participation. The challenge quizzes contained daily self-assessment text messages and motivational replies (intervention only) |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from UMMHC, Northwell Health, VACWM. Recruitment activities started on November 2016.
Participants by arm
| Arm | Count |
|---|---|
| NRT and mHealth Assessment Tool Without Feedback For the comparison group, implementation will be balanced in all variables except the Take a Break Intervention. The investigators will balance the two groups further by having the comparison (NRT-Sampling group) complete mHealth assessments (without feedback or goal-setting) as an attention control.
Participants randomized to the comparison group will only have access to a mHealth assessment tool similar to the Challenge Quizzes but without feedback.
NRT and mHealth assessment tool without feedback: NRT and mHealth assessment tool without feedback | 220 |
| Take a Break as an Augmentation to NRT in Motivation The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a Break is an intervention in which smokers are encouraged to engage in smoking abstinence. The main element, the Break, is a two-week challenge where smokers report days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge Quizzes (ecological momentary assessments) collect information to guide the smokers during the Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of the Marathon, our Tobacco Treatment Specialist will call all smokers, assess their experiences and collect data.Participants in the intervention will receive the full tool suite.
Take a Break as an augmentation to NRT-sampling in Motivation Phase: NRT sampling experience & Suite of mHealth motivational tools and mini-games. | 213 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 49 | 53 |
Baseline characteristics
| Characteristic | NRT and mHealth Assessment Tool Without Feedback | Take a Break as an Augmentation to NRT in Motivation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 43 Participants | 38 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants | 163 Participants | 332 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 15 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 190 Participants | 197 Participants | 387 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 220 participants | 213 participants | 433 participants |
| Sex: Female, Male Female | 108 Participants | 115 Participants | 223 Participants |
| Sex: Female, Male Male | 112 Participants | 98 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 220 | 0 / 213 |
| other Total, other adverse events | 0 / 220 | 0 / 213 |
| serious Total, serious adverse events | 0 / 220 | 0 / 213 |
Outcome results
Primary
Time to First Quit Attempt
Time to first quit attempt is measured by participant self-report of number of days from baseline to first quit attempt within a 6 month period. At the 6-month follow-up visit, the dates of all quit attempts were assessed using the Timeline Follow-Back Method and used to calculate time to first quit attempt.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Time to First Quit Attempt | 0.89 days | Standard Deviation 1.04 |
| Take a Break as an Augmentation to NRT in Motivation | Time to First Quit Attempt | 1.48 days | Standard Deviation 2.29 |
Comparison: The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards modelsp-value: 0.0295% CI: [1.09, 2.6]Regression, Cox
Secondary
Change in Self-Efficacy at the End of the 6 Months
Self Efficacy is measured by the Self-Efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item instrument (two six-item subscales) that measures the confidence in ability to refrain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers). The scale varies from 1-5 \[Not at all (1) Not very(2) Moderately(3) Very (4) Extremely (5)\] A higher score indicates a higher level of confidence to refrain from smoking in certain social or emotional situations and a lower score indicates a lower level of confidence to refrain from smoking.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Change in Self-Efficacy at the End of the 6 Months | 2.7 SEQ-12 overall score (mean) | Standard Deviation 0.9 |
| Take a Break as an Augmentation to NRT in Motivation | Change in Self-Efficacy at the End of the 6 Months | 2.9 SEQ-12 overall score (mean) | Standard Deviation 1 |
Comparison: For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.p-value: 0.03Regression, Linear
Secondary
Mean Number of Days Abstinent During the First 3 Weeks
Measure the mean number of days abstinent as self-reported by participant via the mHealth assessment.
Time frame: 3 Weeks
Population: The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to self-reported the number of days abstinent at three weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Mean Number of Days Abstinent During the First 3 Weeks | 0.60 days | Standard Deviation 2.38 |
| Take a Break as an Augmentation to NRT in Motivation | Mean Number of Days Abstinent During the First 3 Weeks | 1.20 days | Standard Deviation 3.02 |
Comparison: During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).p-value: 0.01Regression, Linear
Secondary
Number of Participants Abstinent During the First 3 Weeks
Number of participants abstinent within the 3 week period as self-reported by participant via the mHealth assessment. .
Time frame: 3 Weeks
Population: The population analyzed includes participants who eventually dropped out.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Number of Participants Abstinent During the First 3 Weeks | 29 Participants |
| Take a Break as an Augmentation to NRT in Motivation | Number of Participants Abstinent During the First 3 Weeks | 49 Participants |
Secondary
Point Prevalent Cessation as Measured by Carbon Monoxide Levels
Point prevalent cessation here is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Point Prevalent Cessation as Measured by Carbon Monoxide Levels | 17 Participants |
| Take a Break as an Augmentation to NRT in Motivation | Point Prevalent Cessation as Measured by Carbon Monoxide Levels | 28 Participants |
p-value: 0.04895% CI: [1.01, 3.68]Chi-squared
Other Pre-specified
Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal.
Participants in the Intervention group were asked to participate in a goal-setting call to establish a smoking abstinence goal (typically one to two days of abstinence from cigarettes). The outcome measures the number of participants who completed to goal-setting call.
Time frame: 1 week
Population: The number of participants analyzed is higher than the number of participants who completed the study as more participants were able to complete goal setting at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Number of Participants Completing a Call With Study Team to Establish a Smoking Abstinence Goal. | 199 Participants |
Other Pre-specified
Number of Participants Completing Daily Challenge Quiz
Participants were asked to complete daily challenge quizzes during the first 3 weeks of participation. The challenge quizzes contained daily self-assessment text messages and motivational replies (intervention only)
Time frame: 3 weeks
Population: The number of participants analyzed is higher than the number of participants who completed the study as all participants were able to complete daily challenge quizzes at baseline and at three weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Number of Participants Completing Daily Challenge Quiz | 112 Participants |
Other Pre-specified
Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings.
TAB participants were encouraged to use mHealth apps that provide relaxation or distraction to help manage smoking cravings. The study team measured the number of participants used mHealth apps to manage nicotine cravings in a 3 week period.
Time frame: 3 week
Population: The number of participants analyzed varies from number completed to reflect the number of participants still engaged at 3 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Number of Participants Use of Mobile Health Application (mHealth App) to Manage Nicotine Cravings. | 159 Participants |
Other Pre-specified
Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist)
At one week TAB participants were asked to whether they would like to set an abstinence goal for the following 2-week challenge. The outcome measures the number of participants in the TAB group who set a brief abstinence goal
Time frame: 2 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT and mHealth Assessment Tool Without Feedback | Number of TAB Participants Setting a Brief Abstinence Goal With the TTS (Tobacco Treatment Specialist) | 145 Participants |