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
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589277

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Yale University
Investigators
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

ClinicalTrials.gov processed this record on October 01, 2014