RecruitingInterventional

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

NCT ID: NCT07447635Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-05-18

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.

Arms & 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.

Outcome measures

Primary

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 treatment
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 treatment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Christine Vinci, PhD · Principal Investigator

Vani Simmons, PhD · Sub Investigator

Steve Sutton, PhD · Sub Investigator

Margaret Byrne, PhD · Sub Investigator

Kea Turner, PhD · Sub Investigator

Katie Witkiewitz, PhD · Sub Investigator