Bariatric Education for Women With Obesity and Endometrial Cancer

NCT05396794 | Terminated

• 1 other identifier: OU-SCC-BAREDU
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Endometrial Cancer; Bariatric Surgery Candidate

Keywords

bariatric surgery; endometrial cancer; obesity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Standard weight loss education BEHAVIORAL

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

Control Group

Standard weight loss education + Educational Video 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.

Video Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: This study will include women only as it is focused on a sex-specific cancer (endometrial).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Obesity; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura L Holman, MD

  University of Oklahoma Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 31, 2022
• Study Start: August 30, 2023
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)