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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA127818 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.
This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions.
Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered.
Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gain-Framed counseling & Gain-framed materials | Experimental | Novel messages for quitting smoking |
|
| Standard care counseling + standard materials | Placebo Comparator | Standard care counseling + standard care print information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gain-Framed counseling & Gain-framed materials | Behavioral | Novel messages for quitting smoking |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quit Attempt | Percentage of those that self reported attempting to quit smoking at the 2 week follow up. | 2 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Abstinence | The number of survey respondents that had abstained from smoking at the 2 week follow up. | 2 week follow up |
| 7 Day Abstinence | The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin A Toll, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20056957 | Result | Toll BA, Martino S, Latimer A, Salovey P, O'Malley S, Carlin-Menter S, Hopkins J, Wu R, Celestino P, Cummings KM. Randomized trial: Quitline specialist training in gain-framed vs standard-care messages for smoking cessation. J Natl Cancer Inst. 2010 Jan 20;102(2):96-106. doi: 10.1093/jnci/djp468. Epub 2010 Jan 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care Counseling + Standard Care Print Information | Standard care counseling + standard care print information |
| FG001 | Gain-Framed Counseling | Callers were randomly assigned to receive gain-framed counseling messages and received newly developed, exclusively gain-framed NYSSQL printed materials by mail. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care Counseling | Standard care counseling + standard care print information |
| BG001 | Gain-Framed Counseling | Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Quit Attempt | Percentage of those that self reported attempting to quit smoking at the 2 week follow up. | Per protocol | Posted | Number | participants | 2 week follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care Counseling | Standard care counseling + standard care print information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Toll, Ph.D. Associate Professor of Psychiatry | Yale University School of Medicine | (203) 974 5767 | benjamin.toll@yale.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Standard care counseling + standard materials | Behavioral | Standard messages for quitting smoking |
|
| 3 month follow up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | 24 Hour Abstinence | The number of survey respondents that had abstained from smoking at the 2 week follow up. | Per protocol | Posted | Number | participants | 2 week follow up |
|
|
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| Secondary | 7 Day Abstinence | The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up. | Per protocol | Posted | Number | participants | 3 month follow up |
|
|
|
| 0 |
| 1,222 |
| 0 |
| 1,222 |
| EG001 | Gain-Framed Counseling | Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail. | 0 | 810 | 0 | 810 |
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