Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Message Framing for Telephone Quitline Callers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University
ClinicalTrials.gov Identifier:
NCT00589277
First received: January 3, 2008
Last updated: January 2, 2013
Last verified: January 2013

January 3, 2008
January 2, 2013
August 2007
May 2009   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00589277 on ClinicalTrials.gov Archive Site
  • 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.
To examine mediators of message framing effects. [ Time Frame: 1-week and 3-month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Message Framing for Telephone Quitline Callers
Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Smoking
  • Nicotine Dependence
  • Behavioral: "Yale coaching"
    Novel messages for quitting smoking
  • Behavioral: Standard care
    Standard messages for quitting smoking
  • Experimental: 1
    "Yale coaching" counseling + "Yale" print information
    Intervention: Behavioral: "Yale coaching"
  • Placebo Comparator: 2
    Standard care counseling + standard care print information
    Intervention: Behavioral: Standard care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2032
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589277
NCI R21 CA127818, 0705002661
Yes
Benjamin A. Toll, Yale University
Yale University
National Cancer Institute (NCI)
Principal Investigator: Benjamin A Toll, Ph.D. Yale University
Yale University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP