Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| SRI International | INDUSTRY |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
The specific aims of this research are to:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Experimental | 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. |
|
| Quitline treatment as usual (TAU) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced E-cigarette Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after baseline |
| 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). | Phase 2 time frame: 3 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point Prevalence Smoking Cessation Rates | In Phase 2 participants will report their quit status during their outcome survey. | Phase 2 time frame: 3 months after baseline |
| Changes in Use of ENDS, Nicotine Replacement Therapy (NRT), and Cigarettes |
Inclusion Criteria:
• Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program
Exclusion Criteria:
• Pregnant or Planning pregnancy within 3 months
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katrina Vickerman, PHD | Optum, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optum | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34568637 | Result | Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individuals who smoke and vape. Contemp Clin Trials Commun. 2021 Sep 8;24:100845. doi: 10.1016/j.conctc.2021.100845. eCollection 2021 Dec. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analysis focused on 3-month survey respondents (N=66). | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after baseline |
|
Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat d/t reported use of e-cigarette | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katrina Vickerman | Consumer Wellness Solutions | 469-608-4208 | katrina.vickerman@optum.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2018 | May 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2016 | May 16, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Quitline treatment as usual | Behavioral | 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. |
|
|
| 3 months after baseline |
| 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. | Phase 2 time frame: 3 months after baseline |
| 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. | Phase 2 time frame: 3 months after baseline |
| 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. | Phase 2 time frame: 3 months after baseline |
A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.
| Up to 12 weeks |
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | Coaching calls completed | Phase 2 time frame: 3 months after baseline |
|
|
|
| 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. | Analysis focused on 3-month survey respondents (N=66). | Posted | Mean | Standard Error | score on a scale | 3 months after baseline |
|
|
|
| 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. | Respondents to the 3-month survey | Posted | Count of Participants | Participants | Phase 2 time frame: 3 months after baseline |
|
|
|
| Other Pre-specified | 7-Day Point Prevalence Smoking Cessation Rates | In Phase 2 participants will report their quit status during their outcome survey. | Not Posted | Phase 2 time frame: 3 months after baseline | Participants |
| 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. | Not Posted | Up to 12 weeks | 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. | Respondents to the 3-month survey | Posted | Count of Participants | Participants | Phase 2 time frame: 3 months after baseline |
|
|
|
| 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. | Respondents to the 3-month survey | Posted | Count of Participants | Participants | Phase 2 time frame: 3 months after baseline |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 17 |
| 30 |
| EG001 | 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. | 0 | 50 | 0 | 50 | 19 | 33 |
| Headache d/t reported use of e-cigarettes | General disorders | Systematic Assessment |
|
| Breathing difficulties d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Cough d/t reported e-cigarette use | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Bad or vivid dreams/nightmares d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Nausea/stomach upset d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Chest pain d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Skin Irritation - rash, itchiness d/t reported NRT use | General disorders | Systematic Assessment |
|
| Headache d/t reported NRT use | General disorders | Systematic Assessment |
|
| Nausea/stomach upset d/t reported NRT use | General disorders | Systematic Assessment |
|
| Any side effect d/t reported e-cigarette use | General disorders | Systematic Assessment |
|
| Any side effect d/t NRT use | General disorders | Systematic Assessment |
|
Not provided
Not provided
| More Harmful |
|
| I prefer not to answer |
|
| More Harmful |
|
| I Prefer Not to Answer |
|
| More Harmful |
|
| I Prefer Not to Answer |
|