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Bariatric Education for Women With Obesity and Endometrial Cancer (SCC-BAREDU)

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Terminated

Conditions

Endometrial Cancer
Bariatric Surgery Candidate
Obesity

Treatments

Behavioral: Standard weight loss education + Educational Video
Behavioral: Standard weight loss education

Study type

Observational

Funder types

Other

Identifiers

NCT05396794
OU-SCC-BAREDU

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

Control Group
Description:
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.
Treatment:
Behavioral: Standard weight loss education
Video Group
Description:
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.
Treatment:
Behavioral: Standard weight loss education + Educational Video

Trial contacts and locations

1

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Central trial contact

Lead Nurse

Data sourced from clinicaltrials.gov

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