Enacting Active Survivorship: Implementation of Weight Management Strategies in Endometrial Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Percentage of participants referred to weight loss clinic who are able to start weight management medications
Study Overview
Brief Summary
This study is being done to understand how oncologists can engage a multidisciplinary team to help endometrial cancer survivors with obesity to engage in a weight management program and potentially start a weight loss medication. Obesity often impacts the future health and longevity of early-stage endometrial cancer survivors more than their cancer diagnosis.
Patients will be referred to the KUMC OB/Gyn weight management clinic to discuss weight management options.
- If patients decide to use medications for weight loss, then the study will collect data from their chart that is recorded as part of routine monitoring for patients on weight loss medications.
- If patients decide not to use any medications, the study will monitor physical exam and lab data collected as part of their routine medical care.
The study will also try to understand reasons why patients did or did not start using a weight loss medication.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old
- •BMI ≥ 30kg/m2
- •Completed surgical staging with no evidence of residual disease
- •Endometrioid endometrial adenocarcinoma, p53 wild type
- •Undergoing active surveillance +/- brachytherapy
Exclusion Criteria
- •Unable to participate in behavior weight loss
- •Stroke, heart attack, end stage liver disease, or end stage kidney disease during the last 6 months.
- •Currently on a GLP-1 agonist
- •Currently on insulin
Arms & Interventions
Endometrial cancer survivors with weight management
Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2
Intervention: Weight loss with pharmacotherapy (Behavioral)
Endometrial cancer survivors with weight management
Survivors of low-risk early-stage endometrial cancer up to 36 months post primary treatment with body mass index (BMI) ≥30 kg/m2
Intervention: Weight loss without pharmacotherapy (Behavioral)
Outcomes
Primary Outcomes
Percentage of participants referred to weight loss clinic who are able to start weight management medications
Time Frame: 12 months
We will track the number of participants who do and do not start medication. Patients will be offered GLP-1 agonist, naltrexone/bupropion, orlistat, or phentermine/topiramate based discussion with weight management specialist.
Secondary Outcomes
- Change in insulin resistance over 12 months using HgA1c as a surrogate marker in participants on weight loss medications(12 months)
- Change in quality of life as assessed by the Functional Assessment of Cancer Therapy- Gynecology (FACT-G) over 12 months in participants on weight loss medications(12 months)
- Change in depression as assessed by Patient Health Questionnaire-2 (PHQ-2) over 12 months in participants on weight loss medications(12 months)
Investigators
Melissa Javellana
Principal Investigator
University of Kansas Medical Center