NCT01282008

Brief Summary

BACKGROUND: This document outlines the study design and procedures to be used to evaluate a series of corrective statements to augment consumer knowledge and beliefs about smoking as related to past actions of tobacco companies. The statements were ordered by a U.S. Federal Court in U.S. v. Philip Morris USA, Inc., and are intended to target potential misperceptions resultant of past marketing and promotion practices undertaken by the tobacco industry. OBJECTIVES: The U.S. Department of Justice has asked NCI to take the lead on developing and testing corrective statements with adult and youth audiences to ensure both message comprehension and avoidance of unintended consequences of message exposure, such as boomerang effects, smoking triggers, or knowledge gaps. The court has identified five areas that the statements shall address:

  • Current smokers (with an oversample of low socioeconomic status individuals)
  • General population nonsmokers and former smokers (with an oversample of low socioeconomic status individuals)
  • Spanish-speaking Hispanics
  • Youth age 14-17 DESIGN: Both qualitative and quantitative methods (focus groups and post-test comparison group Web-enabled surveys) will be used to develop and test a range of corrective statements in the five areas outlined by the court.
  • Focus group participants: 48-64
  • Survey participants: 2500

Trial Health

80
On Track

Trial Health Score

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

Enrollment
627

participants targeted

Target at P75+ for all trials

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

First Submitted

Initial submission to the registry

January 21, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
Last Updated

December 20, 2019

Status Verified

January 22, 2019

First QC Date

January 21, 2011

Last Update Submit

December 19, 2019

Conditions

Keywords

Online SurveysTobacco Corrective StatementsMessage TestingFocus Groups

Outcome Measures

Primary Outcomes (1)

  • Knowledge

    Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli.

    Immediately upon exposure to stimuli

Study Arms (1)

Focus Groups

Focus Groups about smoking messages

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Random sample of GfK Web panel participants.@@@@@@

You may qualify if:

  • Youth age 14-17
  • Youth current smokers, former smokers, and never smokers
  • Youth male and female genders
  • Youth of all race/ethnicity categories, including: White, Black/African American, Asian, Hispanic/Latino, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander

You may not qualify if:

  • Participants will be excluded from focus groups and survey if they work in:
  • Media
  • Advertising, market research
  • Public health or health promotion
  • An employee of the Federal Govemment who works at HHS or DoJ
  • The tobacco or alcohol industries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Ayanian JZ, Cleary PD. Perceived risks of heart disease and cancer among cigarette smokers. JAMA. 1999 Mar 17;281(11):1019-21. doi: 10.1001/jama.281.11.1019.

    PMID: 10086437BACKGROUND
  • Evans WD, Crankshaw E, Nimsch C, Morgan-Lopez A, Farrelly MC, Allen J. Media and secondhand smoke exposure: results from a national survey. Am J Health Behav. 2006 Jan-Feb;30(1):62-71. doi: 10.5555/ajhb.2006.30.1.62.

    PMID: 16430321BACKGROUND
  • Stryker JE, Moriarty CM, Jensen JD. Effects of newspaper coverage on public knowledge about modifiable cancer risks. Health Commun. 2008 Jul;23(4):380-90. doi: 10.1080/10410230802229894.

    PMID: 18702002BACKGROUND

MeSH Terms

Conditions

SmokingCommunication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kelly D Blake, D.Sc.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 24, 2011

Study Start

January 21, 2011

Last Updated

December 20, 2019

Record last verified: 2019-01-22

Locations