Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Proportion of patient's obesity relevant knowledge pre- and post-education intervention
研究概览
简要总结
The purpose of this study is to examine whether a standardized video education tool will improve knowledge regarding obesity and bariatric surgery and increase bariatric surgery referrals for obese women with endometrial cancer.
详细描述
An estimated 50% of all endometrial cancer cases are associated with obesity. Bariatric surgery has been shown to reduce the risk of hormone-related cancers, including endometrial cancer, by up to 70-80%. This prospective, study of 80 patients will be randomized to either a standard education for weight loss provided by their oncologist or a standard education plus a 15-minute video with information regarding obesity, relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 aged 18-80 with class II or greater obesity (BMI ≥ 35)
- •Have pathologically-confirmed endometrial cancer
- •Have completed initial therapy (e.g. surgery, hormonal therapy, vaginal cuff brachytherapy, or a combination of these modalities) and require no further interventions related to cancer care. Patients taking hormonal therapy as part of cancer treatment may be included.
排除标准
- •Under the age of 18 or over the age of 80
- •Have previously undergone bariatric surgery
- •Requires ongoing cancer treatment with chemotherapy or whole pelvic radiation.
- •Poor surgical candidate secondary to comorbidities or performance status.
结局指标
主要结局
Proportion of patient's obesity relevant knowledge pre- and post-education intervention
时间窗: 6 Months
Proportion of patient will complete a pre and post (6 months after enrollment) survey to examine the knowledge of obesity, endometrial cancer and bariatric surgery. These measures will be self-reported 6 months after the patient was educated on the benefits of weight loss.
Proportion of patients who chose to take part in bariatric surgery.
时间窗: 6 Months
Based on these pre-and post-educational surveys patient's decision to participate or to decline the bariatric surgery referral will be recorded, including the patients experience with bariatric surgery program.
次要结局
未报告次要终点