Alcohol Use, Smoking Cessation
Conditions
Keywords
Mindfulness-based intervention, Cancer survivors, Smoking cessation, Alcohol use
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.
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
BEHAVIORALMindfulness-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.
BEHAVIORALQuitline 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Florida Biomedical Research Program - James & Esther King
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence | 6 months post treatment | Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine \<10 ng/mL. |
| Percent Heavy Drinking Days (Past 4 Weeks) | 6 months post treatment | Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women) |
Countries
United States
Contacts
CONTACTSkye Dougan, MPH
CONTACTMarilyn Horta, PhD
PRINCIPAL_INVESTIGATORChristine Vinci, PhD
Moffitt Cancer Center
Outcome results
None listed