RecruitingNot ApplicableNCT06461650

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Sponsor

University of Florida

Enrollment

20 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success. This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured nicotine cessation program before surgery (mastectomy with reconstruction or lumpectomy with oncoplastics) can help women with breast cancer quit nicotine in time to reduce the risk of surgical complications and improve healing. **You may be eligible if...** - You are a woman between 18 and 80 years old - You have been diagnosed with Stage 0–3 breast cancer confirmed by biopsy - You are scheduled for mastectomy with reconstruction or oncoplastic lumpectomy - You currently use nicotine products (cigarettes, vaping, etc.) and have used them in the past month **You may NOT be eligible if...** - Your surgeon has deemed you ineligible for reconstruction for other reasons (e.g., BMI over 35, inflammatory breast cancer) - You are already enrolled in a different nicotine cessation program - You are pregnant - You cannot complete the study sessions due to language, travel, or technology barriers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNicotine cessation program

Participants will complete up to 4 sessions of a nicotine cessation program over either 12-24 weeks if receiving neoadjuvant therapy (i.e. chemotherapy or hormonal/endocrine therapy) prior to surgery or over 4-6 weeks if not receiving neoadjuvant therapy prior to surgery. Each session will be 30-60 minutes long. Participants receiving neoadjuvant therapy will also be eligible for nicotine replacement therapy; however, it must be stopped 6 weeks before surgery.

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT06461650

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