Overview

This trial is active, not recruiting.

Conditions complex endometrial hyperplasia with atypia, stage ia uterine corpus cancer, stage ib uterine corpus cancer, stage ii uterine corpus cancer
Treatments weight loss specialist, quality-of-life assessment, medical chart review
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date December 2014
End date May 2015
Trial size 127 participants
Trial identifier NCT02342730, CASE13813, NCI-2014-02477, P30CA043703

Summary

This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients are referred to a weight loss specialist for assistance with weight loss and medical chart reviews are performed at baseline and every 3 months for 24 months. Patients complete Quality-of-Life Assessment (EORTC- QLQ-C30 and EORTC-QLQ-EN24) at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.
weight loss specialist Behavior Conditioning Therapy
Referred to a weight loss specialist
quality-of-life assessment Quality of Life Assessment
Complete EORTC-QLQ questionnaires
medical chart review Chart Review
Chart reviews are performed

Primary Outcomes

Measure
Accrual with intervention, defined as number of subjects who agree to participate
time frame: Up to 24 months
Compliance with intervention, defined as number of patients who follow up with the obesity referral
time frame: Up to 24 months

Secondary Outcomes

Measure
Weight loss (in kilograms)
time frame: Baseline to 12 months
Weight loss (in kilograms)
time frame: Baseline to 24 months
Compliance with lifestyle changes (based on affirmative response to 3 month follow up when asked if lifestyle changes have been adopted)
time frame: At 3 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
time frame: Baseline
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
time frame: At 12 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
time frame: At 24 months
Progression free survival
time frame: Up to 24 months
Overall survival
time frame: Up to 24 months
Recurrence rate
time frame: Up to 24 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
time frame: At 12 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
time frame: At 24 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - Women with a history of stage I or II endometrial cancer or a diagnosis of complex atypical hyperplasia - BMI of at least 30 kg/msq Exclusion Criteria: - Advanced disease (stage III or greater) - Recurrent or progressive endometrial cancer - Non endometrioid histology (such as serous uterine cancer or uterine carcinosarcoma) - History of bariatric surgery for weight loss - Ongoing medically supervised weight loss (under the care of a physician) - Poorly controlled psychiatric or medical conditions - Active second primary malignancy

Additional Information

Official title Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
Principal investigator Amelia Jernigan
Description PRIMARY OBJECTIVES: I. To determine the feasibility of a larger project that would aim to describe the health benefits and risks of a weight loss intervention in women who are endometrial cancer survivors with a low risk for recurrence or who have had complex atypical hyperplasia. OUTLINE: Patients are referred to a weight loss specialist for assistance with weight loss and chart reviews are performed at baseline and every 3 months for 24 months. Patients complete the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-Cancer (C)30 and EORTC-QLQ-Endometrial Cancer (EN)24 at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.