Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-09 @ 12:21 PM
Study NCT ID:
NCT05396794
Status:
TERMINATED
Last Update Posted:
2025-05-15
First Post:
2022-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Education for Women With Obesity and Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'No Surgeon to perform the operations.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of patient's obesity relevant knowledge pre- and post-education intervention", 'timeFrame': '6 Months', 'description': '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.'}, {'measure': 'Proportion of patients who chose to take part in bariatric surgery.', 'timeFrame': '6 Months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'endometrial cancer', 'obesity'], 'conditions': ['Obesity', 'Endometrial Cancer', 'Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'genderDescription': 'This study will include women only as it is focused on a sex-specific cancer (endometrial).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-80 with class II or greater obesity (BMI ≥ 35)\n* Have pathologically-confirmed endometrial cancer\n* 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.\n\nExclusion Criteria:\n\n* Under the age of 18 or over the age of 80\n* Have previously undergone bariatric surgery\n* Requires ongoing cancer treatment with chemotherapy or whole pelvic radiation.\n* Poor surgical candidate secondary to comorbidities or performance status.'}, 'identificationModule': {'nctId': 'NCT05396794', 'acronym': 'SCC-BAREDU', 'briefTitle': 'Bariatric Education for Women With Obesity and Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Bariatric Surgery Among Women With Obesity and Low Risk Endometrial Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': 'OU-SCC-BAREDU'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Behavioral: Standard weight loss education']}, {'label': '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.', 'interventionNames': ['Behavioral: Standard weight loss education + Educational Video']}], 'interventions': [{'name': 'Standard weight loss education', 'type': 'BEHAVIORAL', 'description': 'Participants will be randomized and given the standard weight loss education by the Gynecologic Oncology provider.', 'armGroupLabels': ['Control Group']}, {'name': 'Standard weight loss education + Educational Video', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Video Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Laura L Holman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Stephenson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}