Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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
Disqualifiers
Pregnancy or lactation
Active psychotic disorder
History of severe alcohol withdrawal
Current use of tobacco cessation medication or other treatments to quit smoking
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
BehavioralMBRP-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
BehavioralParticipants 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)Experimental treatment 1 intervention
Group B: Quitline SupportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine \<10 ng/mL.
Time frame
6 months post treatment2
Percent Heavy Drinking Days (Past 4 Weeks)
Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)
Time frame
6 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Florida Biomedical Research Program - James & Esther King
Collaborator
Source ClinicalTrials.gov