Bariatric Education for Women With Obesity and Endometrial Cancer (SCC-BAREDU)

May 12, 2025 updated by: University of Oklahoma

Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study

The purpose of this study is to examine whether a standardized video education tool will improve knowledge regarding obesity and bariatric surgery and increase bariatric surgery referrals for obese women with endometrial cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

An estimated 50% of all endometrial cancer cases are associated with obesity. Bariatric surgery has been shown to reduce the risk of hormone-related cancers, including endometrial cancer, by up to 70-80%. This prospective, study of 80 patients will be randomized to either a standard education for weight loss provided by their oncologist or a standard education plus a 15-minute video with information regarding obesity, relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Stephenson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women with endometrial cancer with obesity who are receiving care at the Stephenson Cancer Center will be considered for inclusion. All patients regardless of race, ethnicity, or socioeconomic status will be included without discrimination.

Description

Inclusion Criteria:

  • Adults aged 18-80 with class II or greater obesity (BMI ≥ 35)
  • Have pathologically-confirmed endometrial cancer
  • Have completed initial therapy (e.g. surgery, hormonal therapy, vaginal cuff brachytherapy, or a combination of these modalities) and require no further interventions related to cancer care. Patients taking hormonal therapy as part of cancer treatment may be included.

Exclusion Criteria:

  • Under the age of 18 or over the age of 80
  • Have previously undergone bariatric surgery
  • Requires ongoing cancer treatment with chemotherapy or whole pelvic radiation.
  • Poor surgical candidate secondary to comorbidities or performance status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
If the patient is in group 1, she will get standard education for weight loss, which will be provided by her Gynecologic Oncologist. This will take about 15 minutes.
Behavioral: Standard weight loss education
Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.
Video Group
If the patient is in group 2, she will get standard education for weight loss provided by her Gynecologic Oncologist. Then she will be asked to view a 15-minute video to get information regarding obesity, the relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery. These will take about 30 minutes.
Behavioral: Standard weight loss education + Educational Video
Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider followed by a 15-minute educational video detailing the benefits of weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patient's obesity relevant knowledge pre- and post-education intervention
Time Frame: 6 Months
Proportion of patient will complete a pre and post (6 months after enrollment) survey to examine the knowledge of obesity, endometrial cancer and bariatric surgery. These measures will be self-reported 6 months after the patient was educated on the benefits of weight loss.
6 Months
Proportion of patients who chose to take part in bariatric surgery.
Time Frame: 6 Months
Based on these pre-and post-educational surveys patient's decision to participate or to decline the bariatric surgery referral will be recorded, including the patients experience with bariatric surgery program.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in online questionnaire responses pre- and post-intervention.
Time Frame: 6 Months
The subject's knowledge will be assessed using a survey at baseline compared to 6 months later. Unit of measure: % and/or number of respondents.
6 Months
Proportion of subjects who lost weight after being educated on the benefits of weight loss.
Time Frame: 6 Months
The measure will be self-reported 6 months after the subject was educated on the benefits of weight loss.
6 Months
Proportion of subjects who participated in the bariatric seminar.
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Laura L Holman, MD, University of Oklahoma Stephenson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OU-SCC-BAREDU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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