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Recruiting NCT07447635

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

No phase Interventional Smoking Cessation Alcohol Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA), Quitline Support.
Who it may be relevant to
Registry conditions: Smoking Cessation, Alcohol Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Moffitt Cancer Center — Tampa

Identifiers

NCT: NCT07447635 · MCC-23894

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗