Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Breast Cancer Clinical Trial

Official title:

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461650
• Other study ID #: UF-BRE-013
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2029

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2029
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults = 18 years of age and = 75 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Nicotine cessation program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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