Nicotine Cessation for Breast Cancer Patients Undergoing Reconstruction

This study is testing a nicotine cessation program for women with breast cancer who are planning to have breast reconstruction surgery. The program involves up to four sessions over several weeks, depending on whether you receive other treatments like chemotherapy first. The goal is to see if this program is practical and can be successfully offered to patients. You may be able to join if you are a woman between 18 and 80 years old, have Stage 0-3 breast cancer, are recommended for reconstruction, and currently use nicotine products. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study with a planned enrollment of 20 women. The study will assess the feasibility of a nicotine cessation program.
What's involved
Participants will complete up to 4 sessions of a nicotine cessation program over 4-24 weeks, depending on their treatment plan.
Compensation
Not stated in the trial record.
Follow-up
Feasibility will be measured at 12-24 weeks if receiving neoadjuvant therapy, or 4-6 weeks if not receiving neoadjuvant therapy.

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NCT06461650

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Recruiting
NAAges 18–80InterventionalTreatment
University of Florida
~20 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Nicotine cessation program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility
Measured over 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)
Breast Cancer
1 sites across 1 states
Florida1
  • Christiana Shaw, MD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

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

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.
  • Feasibility12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)

    Determine the feasibility of the nicotine cessation program used in this study, as measured by subject participation in at least one program session after study enrollment.