Message Testing for Tobacco-Related Corrective Statements | NCT01282008

Studies
Message Testing for Tobacco-Related Corrective Statements

NCT01282008

Sponsor

National Cancer Institute (NCI)

Status

Completed

Last Update Posted

Dec 20, 2019Actual

Enrollment

627Actual

Phase

Not provided

Conditions

Tobacco
Smoking
Communication

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
11-C-N067

Status Module

Record Verification Date

Jan 22, 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 21, 2011

First Submission Date that Met QC Criteria

Jan 21, 2011

First Posted Date

Jan 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2019

Last Update Posted Date

Dec 20, 2019Actual

Description Module

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:

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

BACKGROUND:

OBJECTIVES:

The court has identified five areas that the statements shall address:

The adverse health effects of smoking;
The addictiveness of smoking and nicotine;
The lack of any significant health benefit from smoking low tar, light, ultra light, mild, and natural cigarettes;
The tobacco industry s manipulation of cigarette design and composition to ensure optimum nicotine delivery;
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:

Focus group participants: 48-64
Survey participants: 2500

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

627Actual

Label	Type	Description	Intervention Names
Focus Groups		Focus Groups about smoking messages

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knowledge	Tobacco-related knowledge, attitudes, and beliefs were measured at baseline and after exposure to message stimuli.	Immediately upon exposure to stimuli

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelly D Blake, D.Sc.	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute (NCI), 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10086437	Background	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.
16430321	Background	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.

ID	Term
D012907	Smoking
D003142	Communication