Message Framing for Telephone Quitline Callers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Nicotine Dependence |
Behavioral: "Yale coaching" Behavioral: Standard care |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers |
- 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.
- 24 Hour Abstinence [ Time Frame: 2 week follow up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.
| Enrollment: | 2032 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
"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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults (18+ years)
- New York State residents
- English-speaking
- Current smokers who utilize Quitline services seeking quitting assistance for themselves
Exclusion Criteria:
- Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Principal Investigator: | Benjamin A Toll, Ph.D. | Yale University |
More Information
Publications:
| Responsible Party: | Benjamin A. Toll, Benjamin Toll, Ph.D. Associate Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT00589277 History of Changes |
| Other Study ID Numbers: | NCI R21 CA127818, 0705002661 |
| Study First Received: | January 3, 2008 |
| Results First Received: | January 2, 2013 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Smoking Tobacco Message Framing |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Substance-Related Disorders Mental Disorders Habits |
ClinicalTrials.gov processed this record on June 17, 2013