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

Primary Purpose

Endometrial Cancer, Overweight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Profile by Sanford weight management plan

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Roger Maris Cancer Center
Sanford Gynecological Oncology clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Profile by Sanford

Arm Description

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.

Outcomes

Primary Outcome Measures

Determine weight change from baseline to 6 months.

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.

All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded.

Secondary Outcome Measures

Full Information

NCT ID

NCT03908996

First Posted

August 14, 2018

Last Updated

March 17, 2021

Sponsor

Sanford Health

1. Study Identification

Unique Protocol Identification Number

NCT03908996

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 11, 2019 (Actual)

Primary Completion Date

January 11, 2021 (Actual)

Study Completion Date

January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Profile by Sanford

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Profile by Sanford weight management plan

Intervention Description

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 Measure Information:

Title

Determine weight change from baseline to 6 months.

Description

All enrolled subjects will be weighed in pounds and the difference from baseline to 6 months will be recorded.

Time Frame

6 months after starting weight management program

Title

Determine weight change from baseline to 12 months.

Description

All enrolled subjects will be weighed in pounds and the difference from baseline to 12 months will be recorded.

Time Frame

12 months after starting weight management program

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Patients who has a diagnosis of endometrial cancer and have completed standard of care treatment.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Bell, MD

Organizational Affiliation

Sanford Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roger Maris Cancer Center

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58102

Country

United States

Facility Name

Sanford Gynecological Oncology clinic

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28097452

Citation

Hoedjes M, van Stralen MM, Joe STA, Rookus M, van Leeuwen F, Michie S, Seidell JC, Kampman E. Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature. J Cancer Surviv. 2017 Jun;11(3):360-385. doi: 10.1007/s11764-016-0594-8. Epub 2017 Jan 18.

Results Reference

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PubMed Identifier

28797697

Citation

Linkov F, Goughnour SL, Ma T, Xu Z, Edwards RP, Lokshin AE, Ramanathan RC, Hamad GG, McCloskey C, Bovbjerg DH. Changes in inflammatory endometrial cancer risk biomarkers in individuals undergoing surgical weight loss. Gynecol Oncol. 2017 Oct;147(1):133-138. doi: 10.1016/j.ygyno.2017.07.144. Epub 2017 Aug 7.

Results Reference

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PubMed Identifier

29137210

Citation

Luo J, Hendryx M, Chlebowski RT. Intentional weight loss and cancer risk. Oncotarget. 2017 Sep 6;8(47):81719-81720. doi: 10.18632/oncotarget.20671. eCollection 2017 Oct 10. No abstract available.

Results Reference

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PubMed Identifier

28973170

Citation

Massetti GM, Dietz WH, Richardson LC. Excessive Weight Gain, Obesity, and Cancer: Opportunities for Clinical Intervention. JAMA. 2017 Nov 28;318(20):1975-1976. doi: 10.1001/jama.2017.15519. No abstract available.

Results Reference

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PubMed Identifier

24369301

Citation

McCarroll ML, Armbruster S, Frasure HE, Gothard MD, Gil KM, Kavanagh MB, Waggoner S, von Gruenigen VE. Self-efficacy, quality of life, and weight loss in overweight/obese endometrial cancer survivors (SUCCEED): a randomized controlled trial. Gynecol Oncol. 2014 Feb;132(2):397-402. doi: 10.1016/j.ygyno.2013.12.023. Epub 2013 Dec 22.

Results Reference

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PubMed Identifier

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Citation

McCarroll ML, Armbruster S, Pohle-Krauza RJ, Lyzen AM, Min S, Nash DW, Roulette GD, Andrews SJ, von Gruenigen VE. Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. Gynecol Oncol. 2015 Jun;137(3):508-15. doi: 10.1016/j.ygyno.2014.12.025. Epub 2015 Feb 11.

Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

Yu J, Feng Q, Wong SH, Zhang D, Liang QY, Qin Y, Tang L, Zhao H, Stenvang J, Li Y, Wang X, Xu X, Chen N, Wu WK, Al-Aama J, Nielsen HJ, Kiilerich P, Jensen BA, Yau TO, Lan Z, Jia H, Li J, Xiao L, Lam TY, Ng SC, Cheng AS, Wong VW, Chan FK, Xu X, Yang H, Madsen L, Datz C, Tilg H, Wang J, Brunner N, Kristiansen K, Arumugam M, Sung JJ, Wang J. Metagenomic analysis of faecal microbiome as a tool towards targeted non-invasive biomarkers for colorectal cancer. Gut. 2017 Jan;66(1):70-78. doi: 10.1136/gutjnl-2015-309800. Epub 2015 Sep 25.

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

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