Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07447635

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

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-05-18

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

F

Florida Biomedical Research Program - James & Esther King

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke and engage in risky alcohol use. The study aims to test how well MBRP-SA works, explore factors that may influence its effects, and assess how it can be implemented in medical and community settings in Florida. The research includes interviews with stakeholders and a cost-effectiveness analysis of both treatment approaches. Participants are randomly assigned to one of two groups. One group receives the MBRP-SA program, a nine-week group mindfulness intervention delivered via Zoom, designed to help reduce smoking and heavy drinking by addressing cravings, stress, and habits. They also receive 10 weeks of nicotine replacement therapy. The other group is connected to the Florida Tobacco Quitline for phone-based counseling and resources for smoking cessation, including up to four weeks of nicotine replacement therapy, along with referrals to community alcohol treatment services. During the study, researchers will assess smoking abstinence and alcohol use six months after treatment using biochemical confirmation and self-reporting of heavy drinking days. Participants will have group sessions and access to counseling or resources depending on their assigned group. The study monitors progress, collects data through interviews, and evaluates outcomes to understand the impact of these approaches. The study is sponsored by H. Lee Moffitt Cancer Center and Research Institute and will continue through 2029.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • History of a cancer diagnosis at any point in lifetime
  • Smoked at least 1 cigarette per day in the past month
  • Had at least one binge drinking episode in the past month or exceeded weekly drinking limits
  • Motivated to quit smoking and reduce alcohol use within the next 30 days
  • Valid home address in Florida
  • Able to speak, read, and write English
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Active psychotic disorder
  • History of severe alcohol withdrawal
  • Currently using tobacco cessation medications or other treatments to quit smoking
  • Receiving end-of-life or hospice care
  • Living with another household member already enrolled in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - 9 to 10 weeks

Participants receive either a nine-week, group-based mindfulness program delivered via Zoom combined with 10 weeks of nicotine replacement therapy, or phone-based counseling and resources through the Florida Tobacco Quitline along with community referrals for alcohol treatment.

Weekly group sessions or phone counseling visits

Follow-up

Duration - 6 months post treatment

Participants are followed for 6 months after treatment to assess smoking abstinence and alcohol use.

Periodic follow-up assessments

Trial Site Locations

Total: 1 location

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

S

Skye Dougan, MPH

M

Marilyn Horta, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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