Message Framing for Telephone Quitline Callers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00589277
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : February 5, 2013
Last Update Posted : February 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University

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.

Condition or disease Intervention/treatment Phase
Smoking Nicotine Dependence Behavioral: "Yale coaching" Behavioral: Standard care Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2032 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quit Attempt [ Time Frame: 2 week follow up ]
    Percentage of those that self reported attempting to quit smoking at the 2 week follow up.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00589277

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Principal Investigator: Benjamin A Toll, Ph.D. Yale University

Publications of Results:
Responsible Party: Benjamin A. Toll, Benjamin Toll, Ph.D. Associate Professor of Psychiatry, Yale University Identifier: NCT00589277     History of Changes
Other Study ID Numbers: NCI R21 CA127818
0705002661 ( Other Grant/Funding Number: NCI R21 CA127818 )
First Posted: January 9, 2008    Key Record Dates
Results First Posted: February 5, 2013
Last Update Posted: February 5, 2013
Last Verified: January 2013

Keywords provided by Benjamin A. Toll, Yale University:
Message Framing

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders