Message Testing for Tobacco-Related Corrective Statements

NCT ID: NCT01282008

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

627 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. The adverse health effects of smoking;
2. The addictiveness of smoking and nicotine;
3. The lack of any significant health benefit from smoking low tar, light, ultra light, mild, and natural cigarettes;
4. The tobacco industry s manipulation of cigarette design and composition to ensure optimum nicotine delivery;
5. The adverse health effects of secondhand smoke.

ELIGIBILITY:

Message testing will be undertaken with the following audiences:

* 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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. The adverse health effects of smoking;
2. The addictiveness of smoking and nicotine;
3. The lack of any significant health benefit from smoking low tar, light, ultra light, mild, and natural cigarettes;
4. The tobacco industry s manipulation of cigarette design and composition to ensure optimum nicotine delivery;
5. The adverse health effects of secondhand smoke.

ELIGIBILITY:

Message testing will be undertaken with the following audiences:

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Smoking Communication

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Online Surveys Tobacco Corrective Statements Message Testing Focus Groups

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Focus Groups

Focus Groups about smoking messages

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kelly D Blake, D.Sc.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10086437 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16430321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18702002 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-C-N067

Identifier Type: -

Identifier Source: secondary_id

999911067

Identifier Type: -

Identifier Source: org_study_id