Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT04965181
Trial Phases:		Protocol IDs:	R01CA237004 (primary) NCI-2021-08950
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Georgia State University
NCI Full Details:	http://clinicaltrials.gov/show/NCT04965181

Summary

The purpose of this study is to:

Aim I: Test the efficacy of a mindfulness-based text messaging program for smoking cessation
("iQuit Mindfully"), both as a standalone intervention and in combination with in-person
counseling; and Aim II: Investigate the mechanisms through which mindfulness training impacts
smoking cessation.

Objectives

This study is a 2 X 2 randomized controlled trial to investigate the effects of the iQuit
Mindfully text messaging program, both as a standalone intervention and in combination with
in-person counseling (Mindfulness-based Addiction Treatment; MBAT), compared to usual care.
Participants will be randomized to one of four groups based on assignment to iQuit Mindfully
text messages (yes/no) and in-person MBAT (yes/no):

- Usual Care (self-help materials + nicotine patch and nicotine lozenge treatment)

- MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch and nicotine
lozenge treatment)

- iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch
and nicotine lozenge treatment)

- MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages +
self-help materials + nicotine patch and nicotine lozenge treatment)

All study participants will receive self-help smoking cessation materials, including the
"Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to
the Tobacco Cessation Quitline (1-800-QUIT-NOW). All study participants will also receive
nicotine patches and lozenges. Assessments will occur at baseline and weeks 1, 3, 5, and 8.
Follow-up assessments will occur at weeks 12 and 24.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.