- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04460417
Chicago Community Health Study (CCHS)
July 1, 2020 updated by: University of Chicago
Health Behavior and Feedback Among Chicago Area Communities
The study examined smokers from the initial COMPASS survey who live in one of three local Census tracks with large concentrations of minority populations and smoking rates, including Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7% smoker), and Bridgeport (34.5% Asian, 27.0%
Hispanic, 29.3% smoker), randomizing them to receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute) versus theoretically-driven and empirically-supported smoking cessation advice session delivered in-person at the UCM.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- 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
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently reside in either the Washington Park, Gage Park, or Bridgeport communities based on current physical address at the time of initial contact for study participation
- Identify as a current smoker (verified by self-report and exhaled carbon monoxide)
- Willing and able to sign an informed consent
- Stable residence and contact information throughout the follow-up period
Exclusion Criteria:
- Not a current smoker
- Does not live within the pre-determined neighborhood locations
- Unable to sign informed consent
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced care
Participants will take part in an approximate one-hour health and smoking feedback session at the University of Chicago in Dr. King's Clinical Addictions Research Laboratory (CARL).
The session will follow the Courage to Quit™ (CTQ) Roadmap program (developed by Dr. King with the Respiratory Health Association).
This roadmap shorter version of the larger CTQ program has been specifically designed as an inpatient bedside or outpatient brief intervention guide to assess smoking cessation motivation, consequences of smoking, facts and myths about smoking, barriers to making a change, approved medications, de-bunking myths about medications or treatments without scientific evidence (e-cigarette, laser treatments, herbals, etc.), and gaining social support.
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The session began with the therapist reviewing the participants' personal feedback sheet within the context of clear messaging that there is no safe level of smoking and of how smoking affects the participant individually and the Black community collectively.
The participant was encouraged to quit smoking, else to reduce smoking if abstinence was not desired, and to use NRT within the next week to help foster behavior change and alleviate withdrawal symptoms.
This portion of the counseling was presented within a culturally-targeted framework such that myths regarding NRT common among persons with low health literacy were discussed and debunked and historical mistrust of the medical community and concerns about exploitation were also addressed.
Each participant in EC was offered a starter kit of NRT with a one week supply of patches or lozenges.
Other Names:
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Active Comparator: Treatment as Usual
Participants will receive the National Cancer Institute (NCI) pamphlet "Clearing the Air" and access to related online resources, which includes brief advice to quit smoking and medication information.
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Participants met with a research assistant for 3-5 minutes and received the National Cancer Institute (NCI) pamphlet "Clearing the Air" and access to related online resources, which includes brief advice to quit smoking and medication information.
They did not receive counseling or specialized care and were advised to refer to the resources should they be interested in quitting smoking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking reduction
Time Frame: Past-week CPD at 1- and 6-month follow-up
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Change in average cigarettes per day (CPD)
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Past-week CPD at 1- and 6-month follow-up
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Quit attempts
Time Frame: Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
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Change in number of any and serious (12+hr) quit attempts
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Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
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Motivation to change smoking
Time Frame: Increases in stage of change at 1- and 6-month follow-ups
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Increase in motivation to change smoking behavior via smoking contemplation ladder (Biener-Abrams Contemplation Ladder) scores.
Scores are on a 10-point scale from 0-10, with higher scores indicating higher motivation to quit smoking.
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Increases in stage of change at 1- and 6-month follow-ups
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Nicotine Replacement Therapy (NRT) use
Time Frame: Any reported NRT use since last session at 1- and 6- month follow-up
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Change in frequency of NRT use
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Any reported NRT use since last session at 1- and 6- month follow-up
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Nicotine Replacement Therapy (NRT) knowledge
Time Frame: More accurate knowledge about NRT at 1- and 6-month follow-ups
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Increase in accurate knowledge about NRT assessed by two items rated from a 1 (strongly disagree) to 7 (strongly agree) scale measuring agreement to the NRT myths, "NRT causes cancer" and "NRT is only used by weak people".
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More accurate knowledge about NRT at 1- and 6-month follow-ups
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea King, PhD, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 1, 2017
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
June 23, 2020
First Submitted That Met QC Criteria
July 1, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- IRB16-1573
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.
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