Message Framing for Telephone Quitline Callers

NCT ID: NCT00589277

Last Updated: 2021-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2032 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Gain-Framed counseling & Gain-framed materials

Novel messages for quitting smoking

Group Type EXPERIMENTAL

Gain-Framed counseling & Gain-framed materials

Intervention Type BEHAVIORAL

Novel messages for quitting smoking

Standard care counseling + standard materials

Standard care counseling + standard care print information

Group Type PLACEBO_COMPARATOR

Standard care counseling + standard materials

Intervention Type BEHAVIORAL

Standard messages for quitting smoking

Interventions

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Gain-Framed counseling & Gain-framed materials

Novel messages for quitting smoking

Intervention Type BEHAVIORAL

Standard care counseling + standard materials

Standard messages for quitting smoking

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin A Toll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20056957 (View on PubMed)

Other Identifiers

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R21CA127818

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0705002661

Identifier Type: -

Identifier Source: org_study_id

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