Educational Intervention for the Promotion of Knowledge and Preventive Health Behaviors Related to Personal Air Pollution Exposure, The Air Study

July 19, 2022 updated by: Fred Hutchinson Cancer Center

Reducing PM2.5 Exposure and Lung Cancer Risk Using Spatial Data Science (The Air Study)

This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure. Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer. The educational intervention is comprised of 2 educational videos that include information regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure and the use of a wearable air pollution sensor. The knowledge gained from this study may inform future research that will be designed to promote awareness of air pollution and its health effects.

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

OUTLINE:

Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants complete questionnaires at weeks 1 and 5.

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.
25

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 18 years or older: The evidence for personal strategies to reduce air pollution exposure has been focused on adults
  • Live in Seattle, WA: The study is designed to focus on Seattle, WA such as using EnviroFlash alerts
  • Own a smartphone: The participant requires a smartphone to setup the Flow app for the air pollution sensor
  • Not traveling in the near-term: The study is designed to assess air pollution patterns in the local Seattle area
  • Leave your home for at least 7 hours per week: Participants will use a wearable air pollution sensor to measure air pollutant levels from indoor and outdoor sources

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Prevention (educational videos, questionnaires)
Participants watch 2 educational videos during week 3 regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure. Participants will use wearable air pollution sensors. Participants will complete questionnaires at weeks 1 and 5.
Other: Questionnaire Administration
Complete questionnaires
Other: Educational Intervention
Watch educational videos and use wearable air pollution sensor
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

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
Changes in knowledge regarding air pollution
Time Frame: At baseline and week 5
Will calculate the proportion of the items that were answered correctly. McNemar's tests will be used to calculate differences in the proportion of participants answering air pollution knowledge items correctly at baseline and at week 5.
At baseline and week 5
Changes in air pollution preventive health behaviors
Time Frame: At baseline and week 5
Will calculate summary scores for air pollution preventive health behaviors and paired t-test to determine intervention effectiveness at baseline and at week 5.
At baseline and week 5

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
Changes in perceived barriers
Time Frame: At baseline and week 5
Summary scores for perceived barriers (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived barriers at baseline and week 5.
At baseline and week 5
Changes in perceived benefits
Time Frame: At baseline and week 5
Summary scores for perceived benefits (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived benefits at baseline and week 5.
At baseline and week 5
Changes in perceived susceptibility
Time Frame: At baseline and week 5
Summary scores for perceived susceptibility (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived susceptibility at baseline and week 5.
At baseline and week 5
Changes in perceived severity
Time Frame: At baseline and week 5
Summary scores for perceived severity (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in perceived severity at baseline and week 5.
At baseline and week 5
Changes in self-efficacy
Time Frame: At baseline and week 5
Summary scores for self-efficacy (guided by the Health Belief Model) will be calculated from participant questionnaire responses by summing the scores across the relevant scale. Paired t-tests will determine changes in self-efficacy at baseline and week 5.
At baseline and week 5
Changes in cues to action
Time Frame: At baseline and week 5
Will calculate frequencies for each cue to action (guided by the Health Belief Model). McNemar's tests will be used to calculate differences in the proportion of participants regarding each cue to action at baseline and week 5.
At baseline and week 5
Changes in air pollutant levels measured using the Flow 2 personal air quality sensor
Time Frame: At baseline and week 2 vs. week 4 and week 5
Paired t-tests will determine changes in air pollutant levels at baseline and week 2 vs. week 4 and week 5.
At baseline and week 2 vs. week 4 and week 5
Intervention feasibility (accessibility)
Time Frame: At week 5
Will report descriptive statistics for intervention accessibility based on responses to the relevant questionnaire items at week 5.
At week 5
Intervention feasibility (acceptability)
Time Frame: At week 5
Will report descriptive statistics for intervention acceptability based on responses to the relevant questionnaire items at week 5.
At week 5
Intervention feasibility (demand)
Time Frame: At week 5
Will report descriptive statistics for intervention demand based on responses to the relevant questionnaire items at week 5.
At week 5
Intervention feasibility (uptake, sensor upload completion)
Time Frame: At baseline through week 5
Will report descriptive statistics the proportion of participants completing sensor uploads.
At baseline through week 5
Intervention feasibility (uptake, educational video viewing)
Time Frame: At week 3
Will report descriptive statistics for the proportion of viewing educational videos at week 3.
At week 3
Intervention feasibility (uptake, questionnaire completion)
Time Frame: At baseline and week 5
Will report descriptive statistics for the proportion of completing the questionnaires at baseline and week 5.
At baseline and week 5

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.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prevent Cancer Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Trang VoPham, Fred Hutch/University of Washington Cancer Consortium

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.
September 15, 2021

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.
January 10, 2022

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.
March 5, 2022

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).
June 1, 2021

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.
June 8, 2021

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.
June 11, 2021

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.
July 21, 2022

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.
July 19, 2022

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.
July 1, 2022

More Information

Terms related to this study

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.
  • RG1121435
  • NCI-2021-04399 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10685 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Lung Carcinoma

Clinical Trials on Questionnaire Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings