Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors

May 15, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.

Study Type

Interventional

Enrollment (Estimated)

600

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Vani Simmons, PhD
        • Sub-Investigator:
          • Katie Witkiewitz, PhD
        • Sub-Investigator:
          • Steve Sutton, PhD
        • Sub-Investigator:
          • Kea Turner, PhD
        • Principal Investigator:
          • Christine Vinci, PhD
        • Sub-Investigator:
          • Margaret Byrne, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥18 years old
  • History of a cancer diagnosis at any point in lifetime
  • Smoked ≥1 cigarette/day in past month
  • At least one binge drinking episode in past month or exceeds weekly drinking limits
  • Motivated to quit smoking and modify alcohol use in next 30 days
  • Valid home address in Florida
  • English-speaking, reading, and writing ability

Exclusion Criteria:

  • Pregnancy or lactation
  • Active psychotic disorder
  • History of severe alcohol withdrawal
  • Current use of tobacco cessation medication or other treatments to quit smoking
  • End-of-life or hospice care
  • Household member already enrolled

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom.
Behavioral: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
MBRP-SA is a nine-week, group-based mindfulness program designed to help cancer survivors quit smoking and reduce heavy alcohol use by targeting craving, stress, and habitual behavior patterns. Participants will also receive 10 weeks of nicotine replacement therapy.
Experimental: Quitline Support
Participants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment.
Behavioral: Quitline Support
Participants will be connected to the Florida Tobacco Quitline, which provides standard evidence-based smoking cessation support, including phone-based counseling, web-based resources, and access to text-messaging programs. The Quitline also offers up to a four-week supply of nicotine replacement therapy (patches, gum, or lozenges). Participants will also receive referrals to various alcohol-related treatment options in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
Time Frame: 6 months post treatment
Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine <10 ng/mL.
6 months post treatment
Percent Heavy Drinking Days (Past 4 Weeks)
Time Frame: 6 months post treatment
Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)
6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Florida Biomedical Research Program - James & Esther King

Investigators

  • Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

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)

May 15, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23894

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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