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

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.

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Key information

Conditions

Endometrial Cancer Body Weight Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Roger Maris Cancer Center, Fargo, North Dakota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Profile by Sanford weight management plan

Behavioral

The purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program.

Primary outcomes

Determine weight change from baseline to 6 months.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Registry information

Official study title

Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 9, 2019
Registry last updated: Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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