Nicotine cessation program for women with breast cancer needing reconstruction
Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
NA · University of Florida · NCT06461650
This study tests a program to help women with breast cancer quit smoking before their surgery to see if it can improve their recovery and overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06461650 on ClinicalTrials.gov |
What this trial studies
This study evaluates a nicotine cessation program specifically designed for women diagnosed with breast cancer who are recommended for surgical reconstruction. It addresses the high prevalence of nicotine use among cancer patients, which is linked to poorer outcomes and increased surgical complications. The program aims to assess its feasibility, acceptability, and preliminary efficacy in helping these women quit nicotine before undergoing surgery. By integrating nicotine cessation with the surgical process, the study seeks to improve overall patient outcomes and emotional well-being.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 80 diagnosed with Stage 0-3 breast cancer who are recommended for reconstruction and actively use nicotine products.
Not a fit: Patients who are not eligible for reconstruction, have significant health issues, or are already participating in another cessation program may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance surgical outcomes and emotional health for women with breast cancer who use nicotine.
How similar studies have performed: While nicotine cessation programs have been studied in various populations, this specific approach targeting breast cancer patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Fieber, MD — University of Florida
- Study coordinator: Judy Walsh
- Email: PMO@cancer.ufl.edu
- Phone: (352) 294-8615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, breast cancer, nicotine cessation, mastectomy, reconstruction, smokers