Impact of Smoking Information on Concerns About Radon

April 17, 2019 updated by: Paul Windschitl
Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers). Participants in both studies were recruited through Amazon's Mechanical Turk (MTurk). Participants viewed radon messages that varied in the information they communicated about smoking's effect on lung cancer. In Study 1, smoking information was included or excluded from messages assembled from existing radon pamphlets. In Study 2, versions of a new radon message either excluded smoking information, described smoking as a major cause of lung cancer, or also described smoking's synergistic effect with radon on lung cancer risk. After viewing a radon health message, participants completed a variety of measures. Primary measures assessed respondents' anticipated sense of concern and related reactions if they learned that they/their home had been exposed to elevated levels of radon. Other key measures included questions about participants' interest and intention to test their home for radon.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Live within the US
  • Have an Amazon Mechanical Turk account (website where online study was posted)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Study 1: Radon&Smoking Synergistic/EPA
Participants viewed radon and smoking risk information taken from the EPA's pamphlet on the dangers of radon gas exposure.
Behavioral: Radon & Smoking Synergistic
Participants viewed health information detailing the risks of developing lung cancer from exposure to radon gas, smoking, and their synergistic effects. This intervention represents the type of information most commonly presented in radon risk communications.
Behavioral: EPA
Health information modeled after the Environmental Protection Agency's (EPA) pamphlet on radon risk.
Active Comparator: Study 1: Radon&Smoking Synergistic/Idaho
Participants viewed radon and smoking risk information taken from Idaho's Department of Health and Human Welfare's pamphlet on the dangers of radon gas exposure.
Behavioral: Radon & Smoking Synergistic
Participants viewed health information detailing the risks of developing lung cancer from exposure to radon gas, smoking, and their synergistic effects. This intervention represents the type of information most commonly presented in radon risk communications.
Behavioral: Idaho
Health information modeled after the Idaho Department of Health and Human Welfare's pamphlet on radon risk.
Experimental: Study 1: Radon Only / EPA
Participants viewed only radon risk information taken from the EPA's pamphlet on the dangers of radon gas exposure.
Behavioral: EPA
Health information modeled after the Environmental Protection Agency's (EPA) pamphlet on radon risk.
Behavioral: Radon Only
Participants viewed health information detailing the risks of developing lung cancer from radon exposure. No information about the risks for developing lung cancer associated with smoking or its synergistic effect with radon exposure are included.
Experimental: Study 1: Radon Only / Idaho
Participants viewed only radon risk information taken from Idaho's Department of Health and Human Welfare's pamphlet on the dangers of radon gas exposure.
Behavioral: Idaho
Health information modeled after the Idaho Department of Health and Human Welfare's pamphlet on radon risk.
Behavioral: Radon Only
Participants viewed health information detailing the risks of developing lung cancer from radon exposure. No information about the risks for developing lung cancer associated with smoking or its synergistic effect with radon exposure are included.
Experimental: Study 2: Radon Only
Participants viewed a radon-only message that focused only on the effect of radon on lung-cancer risk.
Behavioral: Radon Only
Participants viewed health information detailing the risks of developing lung cancer from radon exposure. No information about the risks for developing lung cancer associated with smoking or its synergistic effect with radon exposure are included.
Other: Study 2: Radon and Smoking Isolated
Participants viewed a radon-and-smoking-isolated message that covered the individual effects of radon and of smoking on lung cancer, but without mentioning their synergistic effect.
Behavioral: Radon and Smoking Isolated
Participants viewed health information detailing the risks of developing lung cancer from radon exposure and smoking. No information describing the synergistic effects of smoking and radon exposure on lung cancer risk are included.
Active Comparator: Study 2: Radon & Smoking Synergistic
Participants viewed a radon-and-smoking-synergistic message that covered the individual effects of radon and of smoking but that also included information about their synergistic effect.
Behavioral: Radon & Smoking Synergistic
Participants viewed health information detailing the risks of developing lung cancer from exposure to radon gas, smoking, and their synergistic effects. This intervention represents the type of information most commonly presented in radon risk communications.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Conditional Concern Composite
Time Frame: Immediately post-intervention (approx. 1 minute)
Composite formed from 4 conditional questions assessing concern, perceived impact on risk and comparative risk, and threat--if exposed to radon
Immediately post-intervention (approx. 1 minute)
Interest in Testing Composite
Time Frame: Immediately post-intervention (approx. 2 minutes)
Composite formed from 2 questions assessing importance and intention to test home for radon
Immediately post-intervention (approx. 2 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Worry Elicited by Health Message
Time Frame: Immediately post-intervention (approx. 2 minutes)
Single question assessing worry elicited by the health communication material
Immediately post-intervention (approx. 2 minutes)
Likelihood Judgments about Lung Cancer
Time Frame: Immediately post-intervention (approx. 4 minutes)
Three items assessing perceived likelihood of developing lung cancer
Immediately post-intervention (approx. 4 minutes)
Elect to Leave Email for Raffle
Time Frame: Immediately post-intervention (approx. 4 minutes)
Participants given option to leave email address in case they won one of the 20 radon kits being raffled (Study 2).
Immediately post-intervention (approx. 4 minutes)
Elect to Read More
Time Frame: Immediately post-intervention (approx. 4 minutes)
Participants given option to be presented with more information at the end of the session about testing for radon (Study 2).
Immediately post-intervention (approx. 4 minutes)
Concern about Loved Ones If Exposed to Radon
Time Frame: Immediately post-intervention (approx. 4 minutes)
Rated how concerned they would be about loved ones if they learned their home had high radon (Study 2)
Immediately post-intervention (approx. 4 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paul Windschitl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201507727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data and guide will be made available to other investigators upon request.

IPD Sharing Time Frame

Requested data will be made available upon publication of the project.

IPD Sharing Access Criteria

Please contact corresponding author Dr. Paul Windschitl at paul-windschitl@uiowa.edu

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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