Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Determine weight change from baseline to 6 months.
研究概览
简要总结
The primary purpose of this study is to evaluate the effectiveness of a 12-month comprehensive weight management program on weight change in overweight/obese patients following treatment for endometrial cancer. During the study period, subjects will be monitored for recurrence during routine clinic visits A secondary exploratory purpose of this study will be to evaluate the gut microbiome in this intervention group and the changes that may occur while participating in a weight loss and weight management program.
详细描述
All enrolled subjects will participate in the Profile weight loss and weight management program for a period of 12 months. They will work with a Profile lifestyle coach weekly to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior as done with all Profile members. A comparison of similar retrospective chart reviews based on age, weight in pounds and stage of cancer will be conducted using the Electronic Medical Record (EMR). All enrolled subjects will collect and return a fecal specimen prior to beginning the weight management plan and again after 6 months of participation. The stool sample will be used to understand gut health.
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
盲法说明
A participant will not be informed of the analysis done on their stool samples. The results of the testing done on a participants stool sample will not be entered into the participants medical record.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older with a diagnosis of endometrial cancer
- •No known metastatic disease
- •Has completed all treatment for their endometrial cancer at least 2 months prior to enrollment.
- •Has a BMI (Body Mass Index) of 30 or higher
- •Ability to understand the purpose of study and willingness to sign consent
- •Willingness to collect fecal specimens at the required time points
- •Capable of following the dietary guidelines and instructions for the Profile weight management plan
- •Agrees to sharing information between Profile and Sanford Research study personnel
排除标准
- •BMI (Body Mass Index) less than 30
- •Known metastatic disease
- •Receiving treatment or expected to receive treatment for endometrial cancer or any other cancer
- •Any psychological, familial, sociological conditions that the physician feels will interfere with medical follow-up and compliance on the study
- •Taking insulin for diabetes (oral medications for diabetes allowed)
- •Use of corticosteroids for a chronic medical condition
- •Known liver disease
- •Bowel or stomach disorders that the physician feels would interfere with Profile participation.
- •Any history of malabsorption syndrome or substantial amounts of small bowel or stomach surgery that impairs nutrient absorption
结局指标
主要结局
Determine weight change from baseline to 6 months.
时间窗: 6 months after starting weight management program
All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded.
Determine weight change from baseline to 12 months.
时间窗: 12 months after starting weight management program
All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded.
次要结局
未报告次要终点