Bariatric Education for Women With Obesity and Endometrial Cancer

Study Overview
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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.

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

Conditions
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Obesity, Endometrial Cancer, Bariatric Surgery Candidate

Intervention / Treatment
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* Behavioral: Standard weight loss education
* Behavioral: Standard weight loss education + Educational Video


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>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<br>* Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.<br>|
| Video Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient's obesity relevant knowledge pre- and post-education intervention | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, endometrial cancer, obesity