Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

NCT06461650 | Recruiting DMC

• 2 other identifiers: UF-BRE-013IRB202401102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; nicotine cessation; mastectomy; reconstruction; smokers

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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.

  12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)

Secondary Outcomes (6)

• Acceptability

  10-30 weeks

• Preliminary efficacy

  10-30 weeks

• Short-term impact on nicotine cessation

  10 days prior to surgery

• Long-term impact on nicotine cessation

  12 months postoperatively

• Patient engagement

  12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)

Study Arms (1)

Nicotine cessation program

EXPERIMENTAL

Behavioral: Nicotine cessation program

Interventions

Nicotine cessation program BEHAVIORAL

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.

Nicotine cessation program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Fieber, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Walsh

CONTACT

(352) 294-8615; PMO@cancer.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)