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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07447635
Status
Recruiting
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Conditions

  • Alcohol Use
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) — BEHAVIORAL
    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.
  • Quitline Support — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
    Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom.
  • Experimental: Quitline Support
    Participants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment.

Primary Outcome Measure

Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence [ Time Frame: 6 months post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
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)

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By research site
Moffitt Cancer Center· Tampa, FL

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