Bariatric Education for Women With Obesity and Endometrial Cancer

Obesity Clinical Trial

— SCC-BAREDU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396794
• Other study ID #: OU-SCC-BAREDU
• Status: Recruiting
• Start date: August 30, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Lead Nurse
• Phone: 405.271.8777
• Email: scc-iit-office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Endometrial Cancer
• Endometrial Neoplasms
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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