A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Endometrial Hyperplasia, Grade 1 Endometrial Cancer
About this trial
This is an interventional prevention trial for Endometrial Hyperplasia focused on measuring fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia, premenopausal endometrial cancer
Eligibility Criteria
Inclusion Criteria: Diagnosis of histologically confirmed complex atypical endometrial hyperplasia or grade 1 endometrial cancer. Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible. For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months. Premenopausal woman with a uterus. ECOG performance status of 0-2. At least 18 years of age and no more than 45 years of age. Interested in uterine preservation/fertility-sparing treatment. BMI ≥ 30 kg/m^2. Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry. Prior or current receipt of metformin is allowed. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Prior participation in a weight loss intervention trial within 3 months prior to date of registration. Current, active treatment for any malignant neoplasm with chemotherapy or radiation. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.
Sites / Locations
- Washington University School of Medicine
- University of New Mexico
- University of Oklahoma
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
The levonorgestrel-releasing IUD is used in this study as per standard care. The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.
The levonorgestrel-releasing IUD is used in this study as per standard care. Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. If participants in the enhanced usual care group do not achieve atypia-free uterine preservation (i.e., have not resolved their hyperplasia or grade 1 endometrial cancer) by one year of enrollment and continue to desire uterine preservation with progestin treatment, they will cross over to receive the telemedicine behavioral intervention for the second year.