Message Framing for Telephone Quitline Callers

Smoking Clinical Trial

Official title:

Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589277
• Other study ID #: 0705002661
• Secondary ID: R21CA127818
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.

Description:

This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials 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 Nicotine replacement therapy (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 gain-framed counseling + gain-framed materials 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 gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2032
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• Gain-Framed counseling & Gain-framed materials
Novel messages for quitting smoking
• Standard care counseling + standard materials
Standard messages for quitting smoking

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Attempt	Percentage of those that self reported attempting to quit smoking at the 2 week follow up.	2 week follow up
Secondary	24 Hour Abstinence	The number of survey respondents that had abstained from smoking at the 2 week follow up.	2 week follow up
Secondary	7 Day Abstinence	The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.	3 month follow up