Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
NCT Number: NCT06461650
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: Nicotine cessation program
Sponsor: University of Florida
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-03

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.

Primary Outcome Measures: 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 chemotherapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant chemotherapy prior to surgery)
Secondary Outcome Measures: Acceptability, Determine the acceptability of the nicotine cessation program used in this study, as measured by participant surveys administered at baseline, at completion of the nicotine cessation program sessions, and at 6 weeks postoperatively., 10-30 weeks|Preliminary efficacy, Determine the preliminary efficacy of the nicotine cessation program used in this study, as measured by participant surveys administered at baseline, at completion of the nicotine cessation program sessions, and at 6 weeks postoperatively., 10-30 weeks|Short-term impact on nicotine cessation, Determine the short-term impact on nicotine cessation of the nicotine cessation program used in this study, as measured by cotinine levels 10 days prior to surgery., 10 days prior to surgery|Long-term impact on nicotine cessation, Determine the long-term impact on nicotine cessation of the nicotine cessation program used in this study, as measured by a participant survey administered 12 months postoperatively., 12 months postoperatively|Patient engagement, Determine patient engagement, as measured by number of program sessions completed and which program sessions were completed., 12-24 weeks (if receiving neoadjuvant chemotherapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant chemotherapy prior to surgery)|Surgical procedure, Determine the surgical procedure each participant underwent following completion of the nicotine cessation program, including if the participant had either reconstruction or oncoplastics at the time of this surgery., At surgery