Recruiting

Nicotine Cessation

Sponsor:

University of Florida

Code:

NCT06461650

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nicotine cessation program

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06461650

Start date

Nov 14, 2024

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nicotine cessation program

Interventions

Nicotine 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.

Primary outcome measure

  • Feasibility [ Time Frame: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery) ]

Central Contacts and Locations

Central contacts

Nicole Davila

(352) 273-8429ndavila@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Nicole Davila

352-273-7345ndavila@UFL.EDU

Principal Investigator:

Christiana Shaw, MD

More Information

Sponsor

University of Florida

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • breast cancer
  • nicotine cessation
  • mastectomy
  • reconstruction
  • smokers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-25.