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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04720625
Other study ID # H00018991
Secondary ID 1R01CA240551-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date June 28, 2021
Est. completion date March 2025

Study information

Verified date February 2024
Source University of Massachusetts, Worcester
Contact Reem M Najjar
Phone 774-275-0890
Email Reem.Najjar@umassmed.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date March 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Current smoker - Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education) - English-speaking - Active in care (at least two clinical visits in the last year) - Have a texting-enabled cell phone Exclusion Criteria: - Not a current smoker - Adults unable to consent - Individuals who are not yet adults (infants, children, teenagers) - Prisoners - Pregnant women - Pilot study participants

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adapt2Quit
Motivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages.
Control
Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Baystate Health Springfield Massachusetts
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
University of Massachusetts, Worcester Baystate Health, Johns Hopkins University, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Reported Participant Tobacco Cessation Rate (quit rate) Self-reported 6-month point prevalence cessation (yes/no) will be assessed at 6-month follow-up. 6-months post-randomization
Primary Biochemical Carbon Monoxide (CO) Verification of Tobacco Cessation Biochemical carbon monoxide (CO) verification testing will also be done for a small subset of participants, where 0-6 parts per million (PPM) measures a non-smoker and 7+ PPM indicates a current smoker. 6-months post-randomization
Secondary Time to First Quit Attempt Self-reported date of first quit attempt since starting the study will be assessed through text message response from participant during the 6-month intervention period. From randomization to 6-months post-randomization
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