Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Trial Title: Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

NCT ID: NCT06461650

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Nicotine

Conditions: Keywords:
breast cancer
nicotine cessation
mastectomy
reconstruction
smokers

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Nicotine cessation program
Description: Participants will complete up to 4 sessions of a nicotine cessation program over either 12-24 weeks if receiving neoadjuvant chemotherapy prior to surgery or over 4-6 weeks if not receiving neoadjuvant chemotherapy prior to surgery. Each session will be 30-60 minutes long. Participants receiving neoadjuvant chemotherapy will also be eligible for nicotine replacement therapy; however, it must be stopped 6 weeks before surgery.
Arm group label: Nicotine cessation program

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.

Criteria for eligibility:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Florida

Address:
City: Gainesville
Zip: 32608
Country: United States

Status: Recruiting

Contact:
Last name: Nicole Davila

Phone: 352-273-7345
Email: ndavila@UFL.EDU

Investigator:
Last name: Jennifer Fieber, MD
Email: Principal Investigator

Start date: November 2024

Completion date: March 2029

Lead sponsor:
Agency: University of Florida
Agency class: Other

Source: University of Florida

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06461650