NCT07447635

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2029

First Submitted

Initial submission to the registry

February 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

February 26, 2026

Last Update Submit

May 15, 2026

Conditions

Smoking CessationAlcohol Use

Keywords

Mindfulness-based interventionCancer survivorsSmoking cessationAlcohol use

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    6 months post treatment

Study Arms (2)

Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)

EXPERIMENTAL

Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom.

Behavioral: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)

Quitline Support

EXPERIMENTAL

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.

Behavioral: Quitline Support

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.

Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
Quitline SupportBEHAVIORAL

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.

Quitline Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Smoking CessationAlcohol Drinking

Interventions

Smoking DevicesEthanol

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDrinking Behavior

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and AgricultureAlcoholsOrganic Chemicals

Study Officials

  • Christine Vinci, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Skye Dougan, MPH

CONTACT

813-745-4376Skye.Dougan@moffitt.org

Marilyn Horta, PhD

CONTACT

813-745-3861Marilyn.Horta@moffitt.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 3, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations

US(1)