Recruiting

MBRP-SA vs. Standard Care

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07447635

Conditions

Smoking Cessation

Alcohol Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)

Quitline Support

Study Details

Brief summary:

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.

Conditions

Smoking Cessation

Alcohol Use

Study ID

NCT07447635

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence [ Time Frame: 6 months post treatment ]
  • Percent Heavy Drinking Days (Past 4 Weeks) [ Time Frame: 6 months post treatment ]

Central Contacts and Locations

Central contacts

Skye Dougan, MPH

813-745-4376Skye.Dougan@moffitt.org

Marilyn Horta, PhD

813-745-3861Marilyn.Horta@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Christine Vinci, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Mindfulness-based intervention
  • Cancer survivors
  • Smoking cessation
  • Alcohol use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-05-18.