Bariatric Education for Women With Obesity and Endometrial Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Education
Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.
|
| Video Group If the patient is in group 2, she will get standard education for weight loss provided by your Gynecologic Oncologist; and then she will be asked to view a 15-minute video to get information regarding obesity, relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery. These will take about 30 minutes. |
Behavioral: Educational Video
Participants will be randomized and provided standard weight loss education followed by a 15-minute educational video by the Gynecological Oncology provider.
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects who participated in the bariatric seminar. [6 Months]
Secondary Outcome Measures
- Change in online questionnaire responses pre- and post-intervention. [6 Months]
The subject's knowledge will be assessed using a survey at baseline compared to 6 months later. Unit of measure: % and/or number of respondents.
- Proportion of subjects who lost weight after being educated on the benefits of weight loss. [6 Months]
The measure will be self-reported 6 months after the subject was educated on the benefits of weight loss.
- Proportion of subjects who participated in the bariatric seminar. [1 Year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18-80 with class II or greater obesity (BMI ≥ 35)
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Have pathologically-confirmed endometrial cancer
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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:
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Under the age of 18 or over the age of 80
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Have previously undergone bariatric surgery
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Requires ongoing cancer treatment with chemotherapy or whole pelvic radiation.
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Poor surgical candidate secondary to comorbidities or performance status.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73117 |
Sponsors and Collaborators
- University of Oklahoma
Investigators
- Principal Investigator: Laura Fischer, MD, University of Oklahoma Stephenson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OU-SCC-BAREDU