Bariatric Education for Women With Obesity and Endometrial Cancer

Recruiting

• Conditions: Obesity; Endometrial Cancer; Bariatric Surgery Candidate
• Interventions: Behavioral: Standard weight loss education; Behavioral: Standard weight loss education + Educational Video

• Registration Number: NCT05396794
• Lead Sponsor: University of Oklahoma

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2023-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Standard weight loss education	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.
Video Group	Standard weight loss education + Educational Video	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patient's obesity relevant knowledge pre- and post-education intervention	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.
Proportion of patients who chose to take part in bariatric surgery.	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.

Trial Locations

Locations (1)

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States