ObesitySCC-BAREDUNCT05396794
Bariatric Education for Women With Obesity and Endometrial Cancer
An observational study of Obesity and Endometrial Cancer, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Obesity, Endometrial Cancer, Bariatric Surgery Candidate
- What is being tested?
- Standard weight loss education and Standard weight loss education + Educational Video
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 18 Apr 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study
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.
Read the 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.
- Conditions
- Obesity, Endometrial Cancer, Bariatric Surgery Candidate
- Being tested
- Standard weight loss education, Standard weight loss education + Educational Video
- Keywords
- bariatric surgery, endometrial cancer, obesity
- Medical subject headings
- Obesity, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard weight loss educationBehavioural
Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.
Standard weight loss education + Educational VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard weight loss education + Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 Aug 2023
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Why it stopped: No Surgeon to perform the operations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura L Holman, MD, Principal investigator, University of Oklahoma Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396794
- Sponsor's protocol ID
- OU-SCC-BAREDU
- Acronym
- SCC-BAREDU
- Status last verified
- May 2025
- First submitted
- 11 May 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT05396794
- Acronym / sponsor ID
- SCC-BAREDU / OU-SCC-BAREDU
- Conditions
- Obesity, Endometrial Cancer, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, endometrial cancer, obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No Surgeon to perform the operations.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Behavioral: Standard weight loss educationIf 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 | – | Behavioral: Standard weight loss education + Educational VideoIf 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard weight loss educationParticipants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider. | Behavioural | Control Group |
| Standard weight loss education + Educational VideoParticipants 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. | Behavioural | Video Group |
Primary outcome
Proportion of patient's obesity relevant knowledge pre- and post-education intervention
Time frame: 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.
Time frame: 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.
Results and safety
The study was stopped early (reason given: No Surgeon to perform the operations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura L Holman, MD principal investigator
University of Oklahoma Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Endometrial Cancer, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No Surgeon to perform the operations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patient's obesity relevant knowledge pre- and post-education intervention (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.