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

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ClinicalTrials.gov Identifier: NCT03908996
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Overweight Behavioral: Profile by Sanford weight management plan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled patients will participate in the Profile weight management program
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Preliminary Trial to Evaluate the Effectiveness of the Profile by Sanford Weight Management Program in Endometrial Cancer Patients
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Profile by Sanford
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.
Behavioral: Profile by Sanford weight management plan
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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients who has a diagnosis of endometrial cancer and have completed standard of care treatment.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908996


Contacts
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Contact: Jan Wernisch, BSN 605-312-3324 janet.wernisch@sanfordhealth.org

Locations
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United States, North Dakota
Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58102
Contact: Jan Wernisch, BSN    605-312-3324    janet.wernisch@sanfordhealth.org   
United States, South Dakota
Sanford Gynecological Oncology clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Jan Wernisch, BSN    605-312-3324    janet.wernisch@sanfordhealth.org   
Principal Investigator: Maria Bell, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Principal Investigator: Maria Bell, MD Sanford Health

Publications:

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Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT03908996     History of Changes
Other Study ID Numbers: SH Profile II
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Overweight
Endometrial Neoplasms
Body Weight
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female