Smoking Cessation
Conditions
Keywords
e-cigarette, vaping, electronic nicotine delivery system (ENDS), smoking cessation
Brief summary
The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.
Detailed description
The specific aims of this research are to: 1. Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention. 2. Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids. 3. Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.
Interventions
BEHAVIORALEnhanced E-cigarette Coaching
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
BEHAVIORALQuitline treatment as usual
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Sponsors
University of Oklahoma
SRI International
H. Lee Moffitt Cancer Center and Research Institute
Consumer Wellness Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program * Currently using e-cigarettes * Indicated plan to use e-cigarettes in the next 30 days * English Speaking * 18+ years old * Willing to quit cigarettes in the next 30 days * Consented to receive automated phone outreach via the quitline (TCPA consented) * Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone * Has regular access to email * Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time
Exclusion criteria
* • Pregnant or Planning pregnancy within 3 months * Reported Schizophrenia diagnosis history during registration * Heart attack past 2 weeks * Stroke/Transient Ischemic Attack past 2 weeks * Rapid Irregular heart beat past 6 months * Angina or heart pain past 6 months * Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban) * Previously screened for study * Enrolled via proxy (i.e., did not self-enroll)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) | 3 months after baseline | In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond I don't know or I prefer not to answer. On scale 1-6, 1 is the best outcome. |
| Treatment Engagement: Call Completion | Phase 2 time frame: 3 months after baseline | In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | Phase 2 time frame: 3 months after baseline | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, Compared to cigarettes, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. |
| Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | Phase 2 time frame: 3 months after baseline | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. |
| Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | Phase 2 time frame: 3 months after baseline | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. |
| Quit Plan Development Experience | 3 months after baseline | In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from no effort (0) to every effort was made (4)): How much effort was made to help you understand your options for quitting smoking?, How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?, and How much effort was made to include what matters most to you in creating your plan for quitting smoking?. Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point Prevalence Smoking Cessation Rates | Phase 2 time frame: 3 months after baseline | In Phase 2 participants will report their quit status during their outcome survey. |
| Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes | Up to 12 weeks | A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced E-cigarette Coaching (EEC) The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions. | 46 |
| Quitline Treatment as Usual (TAU) The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor. | 50 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Call 1 completion required to stay in study per consent process (not contacted for 3-month survey) | 10 | 4 |
| Overall Study | Lost to Follow-up | 13 | 17 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Enhanced E-cigarette Coaching (EEC) | Quitline Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 47 Participants | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 11 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 30 Participants | 62 Participants |
| Region of Enrollment United States | 46 participants | 50 participants | 96 participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 16 Participants | 21 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 50 |
| other Total, other adverse events | 17 / 30 | 19 / 33 |
| serious Total, serious adverse events | 0 / 46 | 0 / 50 |
Outcome results
Primary
Treatment Engagement: Call Completion
In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome).
Time frame: Phase 2 time frame: 3 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Treatment Engagement: Call Completion | 3.4 Coaching calls completed | Standard Deviation 0.24 |
| Quitline Treatment as Usual (TAU) | Treatment Engagement: Call Completion | 2.7 Coaching calls completed | Standard Deviation 0.19 |
Primary
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond I don't know or I prefer not to answer. On scale 1-6, 1 is the best outcome.
Time frame: 3 months after baseline
Population: This analysis focused on 3-month survey respondents (N=66).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) | 5.5 units on a scale |
| Quitline Treatment as Usual (TAU) | Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) | 5.0 units on a scale |
Secondary
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, Compared to cigarettes, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Time frame: Phase 2 time frame: 3 months after baseline
Population: Respondents to the 3-month survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | Less Harmful | 22 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | About the Same | 6 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | More Harmful | 0 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | I prefer not to answer | 2 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | I prefer not to answer | 1 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | Less Harmful | 22 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | More Harmful | 5 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | About the Same | 5 Participants |
Secondary
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Time frame: Phase 2 time frame: 3 months after baseline
Population: Respondents to the 3-month survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | Less Harmful | 25 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | About the Same | 1 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | More Harmful | 1 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | I Prefer Not to Answer | 3 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | I Prefer Not to Answer | 0 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | Less Harmful | 32 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | More Harmful | 0 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | About the Same | 1 Participants |
Secondary
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Time frame: Phase 2 time frame: 3 months after baseline
Population: Respondents to the 3-month survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | Less Harmful | 12 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | About the Same | 5 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | More Harmful | 10 Participants |
| Enhanced E-cigarette Coaching (EEC) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | I Prefer Not to Answer | 3 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | I Prefer Not to Answer | 1 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | Less Harmful | 4 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | More Harmful | 19 Participants |
| Quitline Treatment as Usual (TAU) | Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | About the Same | 9 Participants |
Secondary
Quit Plan Development Experience
In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from no effort (0) to every effort was made (4)): How much effort was made to help you understand your options for quitting smoking?, How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?, and How much effort was made to include what matters most to you in creating your plan for quitting smoking?. Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12.
Time frame: 3 months after baseline
Population: Analysis focused on 3-month survey respondents (N=66).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Quit Plan Development Experience | 10.0 score on a scale | Standard Error 0.4 |
| Quitline Treatment as Usual (TAU) | Quit Plan Development Experience | 9.2 score on a scale | Standard Error 0.6 |
Other Pre-specified
7-Day Point Prevalence Smoking Cessation Rates
In Phase 2 participants will report their quit status during their outcome survey.
Time frame: Phase 2 time frame: 3 months after baseline
Other Pre-specified
Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes
A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.
Time frame: Up to 12 weeks