the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer; Overweight
• Interventions: Behavioral: Profile by Sanford weight management plan

• Registration Number: NCT03908996
• Lead Sponsor: Sanford Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-08-14
• Study Start: 2019-02-11
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Profile by Sanford	Profile by Sanford weight management plan	All enrolled subjects are assigned to participate in the Profile by Sanford weight management program for a period of 12 months..Subjects will follow the Profile program and will be provided a nutritional plan which includes consuming Profile nutritional supplements and other food items. Subjects will work with a Profile lifestyle coach to develop a personalized nutrition plan, discuss their activity, and lifestyle behavior. Subjects on this research study will follow the Profile by Sanford weight loss and management plan as all Profile members. All enrolled subjects will collect and return a fecal specimen prior to beginning the Profile by Sanford weight management plan and again after 6 months of participation.

Primary Outcome Measures

Name	Time	Method
Determine weight change from baseline to 6 months.	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.	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.

Trial Locations

Locations (2)

Sanford Gynecological Oncology clinic; 🇺🇸 Sioux Falls, South Dakota, United States

Roger Maris Cancer Center; 🇺🇸 Fargo, North Dakota, United States