Breast Cancer
Conditions
Keywords
breast cancer, nicotine cessation, mastectomy, reconstruction, smokers
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.
Interventions
BEHAVIORALNicotine cessation program
Participants will complete up to 4 sessions of a nicotine cessation program over either 12-24 weeks if receiving neoadjuvant therapy (i.e. chemotherapy or hormonal/endocrine therapy) prior to surgery or over 4-6 weeks if not receiving neoadjuvant therapy prior to surgery. Each session will be 30-60 minutes long. Participants receiving neoadjuvant therapy will also be eligible for nicotine replacement therapy; however, it must be stopped 6 weeks before surgery.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Contacts
CONTACTNicole Davila
PRINCIPAL_INVESTIGATORChristiana Shaw, MD
University of Florida
Outcome results
None listed