Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of participants referred to weight loss clinic who are able to start weight management medications
研究概览
简要总结
This study is being done to understand how oncologists can engage a multidisciplinary team to help endometrial cancer survivors with obesity to engage in a weight management program and potentially start a weight loss medication. Obesity often impacts the future health and longevity of early-stage endometrial cancer survivors more than their cancer diagnosis.
Patients will be referred to the KUMC OB/Gyn weight management clinic to discuss weight management options.
- If patients decide to use medications for weight loss, then the study will collect data from their chart that is recorded as part of routine monitoring for patients on weight loss medications.
- If patients decide not to use any medications, the study will monitor physical exam and lab data collected as part of their routine medical care.
The study will also try to understand reasons why patients did or did not start using a weight loss medication.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •BMI ≥ 30kg/m2
- •Completed surgical staging with no evidence of residual disease
- •Endometrioid endometrial adenocarcinoma, p53 wild type
- •Undergoing active surveillance +/- brachytherapy
排除标准
- •Unable to participate in behavior weight loss
- •Stroke, heart attack, end stage liver disease, or end stage kidney disease during the last 6 months.
- •Currently on a GLP-1 agonist
- •Currently on insulin
研究组 & 干预措施
Endometrial cancer survivors with weight management
Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2
干预措施: Weight loss with pharmacotherapy (Behavioral)
Endometrial cancer survivors with weight management
Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2
干预措施: Weight loss without pharmacotherapy (Behavioral)
结局指标
主要结局
Percentage of participants referred to weight loss clinic who are able to start weight management medications
时间窗: 12 months
We will track the number of participants who do and do not start medication. Patients will be offered GLP-1 agonist, naltrexone/bupropion, orlistat, or phentermine/topiramate based discussion with weight management specialist.
次要结局
- Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications(12 months)
- Change in quality of life as assessed by the Functional Assessment of Cancer Therapy- Gynecology (FACT-G) over 12 months in participants on weight loss medications(12 months)
- Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications(12 months)
研究者
Melissa Javellana
Principal Investigator
University of Kansas Medical Center