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| Name | Class |
|---|---|
| Florida Biomedical Research Program - James & Esther King | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Skye Dougan, MPH | Contact | 813-745-4376 | Skye.Dougan@moffitt.org | |
| Marilyn Horta, PhD | Contact | 813-745-3861 | Marilyn.Horta@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Christine Vinci, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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. |
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