Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nicotine cessation program
干预措施: Nicotine cessation program (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 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.
次要结局
- Acceptability(10-30 weeks)
- Preliminary efficacy(10-30 weeks)
- Short-term impact on nicotine cessation(10 days prior to surgery)
- Long-term impact on nicotine cessation(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))
- Surgical procedure(At surgery)