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Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04965181
Protocol IDs
R01CA237004 (primary)
NCI-2021-08950
Study Sponsor
Georgia State University

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.

Eligibility

  1. at least 18 years of age
  2. current smoker with history of >3 cigarettes/day (and expired carbon monoxide [CO] >6ppm)
  3. motivated to quit within next 30 days
  4. valid home address in the greater Atlanta, GA area
  5. functioning telephone number
  6. can speak, read, and write in English
**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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.