Who is eligible for clinical trial NCT06461650?

Participants must meet protocol criteria for Breast Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06461650 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-22

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction (NCT06461650)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: University of Florida

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).

Location: University of Florida — Gainesville, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Florida — Gainesville, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗