Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Обзор

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.

Вмешательства

• Поведенческое Nicotine 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.

Первичные конечные точки

• Feasibility [Срок оценки: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)]

Вторичные конечные точки (6)

• Acceptability [Срок оценки: 10-30 weeks]
• Preliminary efficacy [Срок оценки: 10-30 weeks]
• Short-term impact on nicotine cessation [Срок оценки: 10 days prior to surgery]
• Long-term impact on nicotine cessation [Срок оценки: 12 months postoperatively]
• Patient engagement [Срок оценки: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)]
• Surgical procedure [Срок оценки: At surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT06461650 · UF-BRE-013 · IRB202401102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗