Clinical trial Recruiting at 1 site Interventional Ages 18 to 80 Women only

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.

More Breast Cancer trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexWomen only
Enrollment20 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedNovember 14, 2024
Main results expectedMarch 2028
Study endsMarch 2029
Registry record updatedJune 25, 2026
Trial IDNCT06461650 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.