Message Framing for Telephone Quitline Callers
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| Tracking Information | |||||
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| First Received Date ICMJE | January 3, 2008 | ||||
| Last Updated Date | January 2, 2013 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Quit Attempt [ Time Frame: 2 week follow up ] [ Designated as safety issue: No ] Percentage of those that self reported attempting to quit smoking at the 2 week follow up. |
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| Original Primary Outcome Measures ICMJE |
Efficacy data from the clinical trial will be used to determine effect size estimates for both 1-week and 3-month self-reported point prevalence abstinence rates. [ Time Frame: 1-week and 3-month ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00589277 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
To examine mediators of message framing effects. [ Time Frame: 1-week and 3-month ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Message Framing for Telephone Quitline Callers | ||||
| Official Title ICMJE | Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers | ||||
| Brief Summary | The purpose of this study is to compare "Yale coaching" counseling and "Yale" print information to standard care counseling and standard care print information. We hypothesize that "Yale coaching" counseling and "Yale" information will produce higher abstinence rates than standard care counseling and standard care information. We will use these data to determine effect size estimates for a large scale study. |
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| Detailed Description | This pilot study is meant to be translational (i.e., we expect that positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, we will follow the standard practices of the Quitline. In this context, a randomized pilot clinical trial comparing exclusively "Yale coaching" counseling + "Yale" print materials (YC condition) to standard care Quitline counseling + standard print materials (SC condition) 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 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 "Yale coaching" counseling 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 YC counseling and YC print materials, as predicted, are more likely to promote smoking cessation. We will also administer several brief measures that assess potential mediators of treatment. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. Epub 2010 Jan 7. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2032 | ||||
| Completion Date | May 2009 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00589277 | ||||
| Other Study ID Numbers ICMJE | NCI R21 CA127818, 0705002661 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Benjamin A. Toll, Yale University | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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