NCT00589277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,032

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 5, 2013

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

January 3, 2008

Results QC Date

January 2, 2013

Last Update Submit

August 5, 2021

Conditions

Keywords

SmokingTobaccoMessage Framing

Outcome Measures

Primary Outcomes (1)

  • Quit Attempt

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

    2 week follow up

Secondary Outcomes (2)

  • 24 Hour Abstinence

    2 week follow up

  • 7 Day Abstinence

    3 month follow up

Study Arms (2)

Gain-Framed counseling & Gain-framed materials

EXPERIMENTAL

Novel messages for quitting smoking

Behavioral: Gain-Framed counseling & Gain-framed materials

Standard care counseling + standard materials

PLACEBO COMPARATOR

Standard care counseling + standard care print information

Behavioral: Standard care counseling + standard materials

Interventions

Novel messages for quitting smoking

Gain-Framed counseling & Gain-framed materials

Standard messages for quitting smoking

Standard care counseling + standard materials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18+ years)
  • New York State residents
  • English-speaking
  • Current smokers who utilize Quitline services seeking quitting assistance for themselves

You may not qualify if:

  • Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related 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 20;102(2):96-106. doi: 10.1093/jnci/djp468. Epub 2010 Jan 7.

MeSH Terms

Conditions

SmokingTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Benjamin Toll, Ph.D. Associate Professor of Psychiatry
Organization
Yale University School of Medicine

Study Officials

  • Benjamin A Toll, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 9, 2008

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 26, 2021

Results First Posted

February 5, 2013

Record last verified: 2021-08

Locations