Bariatric Education for Women With Obesity and Endometrial Cancer

NCT ID: NCT05396794

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-30

Study Completion Date

2025-04-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Endometrial Cancer Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Standard weight loss education

Intervention Type BEHAVIORAL

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.

Standard weight loss education + Educational Video

Intervention Type BEHAVIORAL

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.

Interventions

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Standard weight loss education

Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura L Holman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Stephenson Cancer Center

Locations

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Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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OU-SCC-BAREDU

Identifier Type: -

Identifier Source: org_study_id

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