NCT04460417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

June 23, 2020

Last Update Submit

July 1, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Smoking reduction

    Change in average cigarettes per day (CPD)

    Past-week CPD at 1- and 6-month follow-up

  • Quit attempts

    Change in number of any and serious (12+hr) quit attempts

    Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up

  • Motivation to change smoking

    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.

    Increases in stage of change at 1- and 6-month follow-ups

  • Nicotine Replacement Therapy (NRT) use

    Change in frequency of NRT use

    Any reported NRT use since last session at 1- and 6- month follow-up

  • Nicotine Replacement Therapy (NRT) knowledge

    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".

    More accurate knowledge about NRT at 1- and 6-month follow-ups

Study Arms (2)

Enhanced care

EXPERIMENTAL

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.

Behavioral: Enhanced Care

Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: TAU

Interventions

Enhanced CareBEHAVIORAL

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.

Also known as: EC
Enhanced care
TAUBEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not a current smoker
  • Does not live within the pre-determined neighborhood locations
  • Unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Brett EI, Chavarria J, Liu M, Hedeker D, King AC. Effects of a brief motivational smoking intervention in non-treatment seeking disadvantaged Black smokers. J Consult Clin Psychol. 2021 Apr;89(4):241-250. doi: 10.1037/ccp0000629. Epub 2021 Mar 11.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrea King, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 7, 2020

Study Start

October 1, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations