Addressing Tetrachloroethylene Exposure in an Impacted Community
Primary Purpose
Vapors; Inhalation, Cancer, Volatile Organic Compounds
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Environmental educational campaign
Sponsored by
About this trial
This is an interventional other trial for Vapors; Inhalation focused on measuring Tetrachloroethylene, Trichloroethylene, PCE, TCE, Community environmental contamination, Chlorinated volatile organic compounds
Eligibility Criteria
Inclusion Criteria: Residents of Martinsville, Indiana 18-64 years of age
Sites / Locations
- Purdue UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Martinsville Residents
Arm Description
Residents of Martinsville, Indiana, will receive educational campaign promoting participation in environmental testing
Outcomes
Primary Outcome Measures
Change in concerns about environmental chemical contamination in Martinsville.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you concerned about environmental chemical contamination in Martinsville? Yes / Somewhat / No / Refuse
1a. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (online survey administered at the beginning of Year 3).
1b. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 5. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention).
Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville.
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you aware of possible exposure to chemicals from soil or groundwater in Martinsville? Yes / No / Refuse
2a. Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey administered at the beginning of Year 3).
2b. Changes in awareness of available resources for exposure reduction from Year 1 to Year 5. This is based on the differences in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Change in willingness to have respondent's homes tested for chemical contamination from contaminated soil or groundwater.
This measure is based on the difference between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you willing to have your home tested for chemical contamination from contaminated soil or groundwater? Yes / No / Refuse / Don't know.
3a. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey at the beginning of Year 3)
3b. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 5. This is based on the differences in differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Secondary Outcome Measures
Full Information
NCT ID
NCT05819996
First Posted
December 5, 2022
Last Updated
April 6, 2023
Sponsor
Purdue University
Collaborators
University of Illinois at Chicago, Indiana University School of Medicine, Mackey Children's Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05819996
Brief Title
Addressing Tetrachloroethylene Exposure in an Impacted Community
Official Title
Addressing Tetrachloroethylene Exposure in an Impacted Community: Residents' Concerns, Neurotoxic Effects, and Exposure Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
University of Illinois at Chicago, Indiana University School of Medicine, Mackey Children's Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Groundwater in Martinsville, IN, is contaminated by volatile organic compounds (VOCs), tetrachloroethylene (PCE) and trichloroethylene (TCE). Indoor air in some residential and commercial buildings is also contaminated with PCE and TCE. This study is being conducted to better understand the impact of low-level exposures to these compounds on community members' health. Data collected in this study will be used to help the community identify a course of action.
Detailed Description
Martinsville, IN, is a community of 11,000 people that overlays four groundwater contamination sites, including a U.S. Environmental Protection Agency (EPA)-designated Superfund site. The total area of groundwater contamination is over 60 acres and lies within a single aquifer. The contaminates are chlorinated volatile organic compounds (VOCs), primarily tetrachloroethylene (PCE) and trichloroethylene (TCE). These contaminants are thought to originate from several dry cleaning and metal degreasing operations. An activated carbon filtration system has been in operation since 2005 to remove PCE and chlorinated VOCs from the municipal water, which now meets EPA drinking water standards. However, a recent report from the Agency for Toxic Substances and Disease Registry concludes that people's health may be harmed by breathing indoor air contaminated via vapor intrusion, the migration of volatile compounds from contaminated groundwater and soil into buildings above. The long-term goal of this research is to understand how PCE exposure in communities affects health and to empower community members' participation in environmental health decision-making. In this project researchers will work with the community of Martinsville, IN to:
Determine the extent and exposure levels to the contaminants by measuring the contamination in residents and at their homes.
Assess the community's concern and perceptions about the contamination and associated health risks.
Study the impact of the contaminants on visual and neurocognitive functions.
Compare cancer rates in Martinsville to county and state rates.
The above information will help researchers and community partners co-design a targeted educational campaign to reduce community members' exposure to the contaminants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vapors; Inhalation, Cancer, Volatile Organic Compounds
Keywords
Tetrachloroethylene, Trichloroethylene, PCE, TCE, Community environmental contamination, Chlorinated volatile organic compounds
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An educational campaign targeting the community
Masking
None (Open Label)
Allocation
N/A
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Martinsville Residents
Arm Type
Other
Arm Description
Residents of Martinsville, Indiana, will receive educational campaign promoting participation in environmental testing
Intervention Type
Behavioral
Intervention Name(s)
Environmental educational campaign
Intervention Description
Educational campaign will be conducted to promote participation in indoor air testing.
Primary Outcome Measure Information:
Title
Change in concerns about environmental chemical contamination in Martinsville.
Description
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you concerned about environmental chemical contamination in Martinsville? Yes / Somewhat / No / Refuse
1a. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (online survey administered at the beginning of Year 3).
1b. Changes in concerns about environmental chemical contamination in Martinsville from Year 1 to Year 5. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention).
Time Frame
For Measure 1a, Time frame is from year 1 to year 3; for Measure 1b, Time frame is from year 1 to year 5.
Title
Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville.
Description
This measure is based on the differences between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you aware of possible exposure to chemicals from soil or groundwater in Martinsville? Yes / No / Refuse
2a. Changes in awareness of possible exposure to chemicals from soil or groundwater in Martinsville from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey administered at the beginning of Year 3).
2b. Changes in awareness of available resources for exposure reduction from Year 1 to Year 5. This is based on the differences in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Time Frame
For Measure 2a, Time frame is from year 1 to year 3; for Measure 2b, Time frame is from year 1 to year 5.
Title
Change in willingness to have respondent's homes tested for chemical contamination from contaminated soil or groundwater.
Description
This measure is based on the difference between the percentage of "Yes" responses to a close-ended, not scaled question at 3 different time points, administered via repeated surveys to the same sample of respondents.
Are you willing to have your home tested for chemical contamination from contaminated soil or groundwater? Yes / No / Refuse / Don't know.
3a. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 3. This is based on the differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 3 (Online survey at the beginning of Year 3)
3b. Changes in willingness to have respondents' homes tested for the chemical contamination from Year 1 to Year 5. This is based on the differences in differences in percentage of yes responses to this question in surveys administered in Year 1 (Main survey, baseline) and Year 5 (Online survey, post intervention)
Time Frame
For Measure 3a, Time frame is from year 1 to year 3; for Measure 3b, Time frame is from year 1 to year 5.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Residents of Martinsville, Indiana
18-64 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sa Liu, MPH, PhD
Phone
765-496-6240
Email
saliu@purdue.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sa Liu, MPH, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sa Liu, PhD
Phone
765-496-6240
Email
saliu@purdue.edu
First Name & Middle Initial & Last Name & Degree
Monica M Bozymski, MS
Phone
765-496-4823
Email
mbozymsk@purdue.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Addressing Tetrachloroethylene Exposure in an Impacted Community
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