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Message Framing for Telephone Quitline Callers

Primary Purpose

Smoking, Nicotine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gain-Framed counseling & Gain-framed materials
Standard care counseling + standard materials
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Tobacco, Message Framing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gain-Framed counseling & Gain-framed materials

Standard care counseling + standard materials

Arm Description

Novel messages for quitting smoking

Standard care counseling + standard care print information

Outcomes

Primary Outcome Measures

Quit Attempt
Percentage of those that self reported attempting to quit smoking at the 2 week follow up.

Secondary Outcome Measures

24 Hour Abstinence
The number of survey respondents that had abstained from smoking at the 2 week follow up.
7 Day Abstinence
The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.

Full Information

First Posted
January 3, 2008
Last Updated
August 5, 2021
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00589277
Brief Title
Message Framing for Telephone Quitline Callers
Official Title
Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence
Keywords
Smoking, Tobacco, Message Framing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2032 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gain-Framed counseling & Gain-framed materials
Arm Type
Experimental
Arm Description
Novel messages for quitting smoking
Arm Title
Standard care counseling + standard materials
Arm Type
Placebo Comparator
Arm Description
Standard care counseling + standard care print information
Intervention Type
Behavioral
Intervention Name(s)
Gain-Framed counseling & Gain-framed materials
Intervention Description
Novel messages for quitting smoking
Intervention Type
Behavioral
Intervention Name(s)
Standard care counseling + standard materials
Intervention Description
Standard messages for quitting smoking
Primary Outcome Measure Information:
Title
Quit Attempt
Description
Percentage of those that self reported attempting to quit smoking at the 2 week follow up.
Time Frame
2 week follow up
Secondary Outcome Measure Information:
Title
24 Hour Abstinence
Description
The number of survey respondents that had abstained from smoking at the 2 week follow up.
Time Frame
2 week follow up
Title
7 Day Abstinence
Description
The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.
Time Frame
3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin A Toll, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20056957
Citation
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.
Results Reference
result

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Message Framing for Telephone Quitline Callers

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