Nicotine cessation program for women with breast cancer needing reconstruction
Official title: Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
Run by University of Florida · NCT06461650 · Data updated 2026-11-12
This study tests a program to help women with breast cancer quit smoking before their surgery to see if it can improve their recovery and overall health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | March 2028 |
| Study ends | March 2029 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT06461650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 80 diagnosed with Stage 0-3 breast cancer who are recommended for reconstruction and actively use nicotine products.
✕Probably not a fit
Patients who are not eligible for reconstruction, have significant health issues, or are already participating in another cessation program may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates a nicotine cessation program specifically designed for women diagnosed with breast cancer who are recommended for surgical reconstruction. It addresses the high prevalence of nicotine use among cancer patients, which is linked to poorer outcomes and increased surgical complications. The program aims to assess its feasibility, acceptability, and preliminary efficacy in helping these women quit nicotine before undergoing surgery. By integrating nicotine cessation with the surgical process, the study seeks to improve overall patient outcomes and emotional well-being.
Why it matters
Potential benefit: If successful, this program could enhance surgical outcomes and emotional health for women with breast cancer who use nicotine.
How similar studies have gone: While nicotine cessation programs have been studied in various populations, this specific approach targeting breast cancer patients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥ 18 years of age and ≤ 80 years of age. * Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy * Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy * Participants who actively use nicotine products defined as any self-reported nicotine use within the past month * Participant agrees to comply with all the study-related procedures. Exclusion Criteria: * Patients not eligible for reconstruction or oncoplastics for other reasons including BMI\>35 or inflammatory breast cancer or based on surgeon discretion. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness. * Patients unable to complete the sessions because of language, travel or technology barriers * Patients already actively participating in another cessation program * Patients who are pregnant.
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Christiana Shaw, MD — University of Florida
- Study coordinator: Nicole Davila
- Email: ndavila@ufl.edu
- Phone: (352) 273-8429
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.