Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Behavioral: Nicotine cessation program

• Registration Number: NCT06461650
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Study Start: 2024-11-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine cessation program	Nicotine cessation program	-

Primary Outcome Measures

Name	Time	Method
Feasibility	12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	10-30 weeks	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.
Preliminary efficacy	10-30 weeks	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.
Short-term impact on nicotine cessation	10 days prior to surgery	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.
Long-term impact on nicotine cessation	12 months postoperatively	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.
Patient engagement	12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)	Determine patient engagement, as measured by number of program sessions completed and which program sessions were completed.
Surgical procedure	At surgery	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States