Message Framing for Telephone Quitline Callers
|ClinicalTrials.gov Identifier: NCT00589277|
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : February 5, 2013
Last Update Posted : February 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Smoking Nicotine Dependence||Behavioral: "Yale coaching" Behavioral: Standard care||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2032 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
"Yale coaching" counseling + "Yale" print information
Behavioral: "Yale coaching"
Novel messages for quitting smoking
Placebo Comparator: 2
Standard care counseling + standard care print information
Behavioral: Standard care
Standard messages for quitting smoking
- Quit Attempt [ Time Frame: 2 week follow up ]Percentage of those that self reported attempting to quit smoking at the 2 week follow up.
- 24 Hour Abstinence [ Time Frame: 2 week follow up ]The number of survey respondents that had abstained from smoking at the 2 week follow up.
- 7 Day Abstinence [ Time Frame: 3 month follow up ]The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589277
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Benjamin A Toll, Ph.D.||Yale University|