Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia

Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Stage II Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Complex Endometrial Hyperplasia With Atypia
• Intervention / Treatment: Behavioral: Weight Loss Specialist; Other: Quality-of-Life Assessment; Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVES:

I.Our primary outcome for the purposes of the pilot study will be to describe recruitment in terms of accrual (number of subjects who agree to participate) and compliance (number of patients who follow up with the obesity referral). This will be described in terms of a specific number as well as a rate.

• Accrual rate is the number of women accrued divided by the number of women approached for the study.
• Compliance rate is the number of women who comply with the referral divided by the number of women accrued.

Several secondary outcomes will be described:

• Weight loss at 12 & 24 months.
• Obesity interventions implemented (medical, surgical, behavioral, and selfguided)
• The incidence of obesity related comorbidities at baseline and 12 and 24 months (myocardial infarction, venous thromboembolism, stroke, diabetes and hypertension.)
• Cancer specific outcomes (recurrence rate, progression free survival).
• Mortality otucomes (Overall survival, cause of death)
• In patients with diabetes, we will record the number of diabetic medications required and the most recent hemoglobin A1C.
• In patients with hypertension, we will record the number of antihypertensive medications required

• We will assess the level of functioning, quality of life and symptomatology of women at baseline, 12 and 24 months using the EORTC-QLQ-C30 and EORTC-QLQ-EN24.

  • Primary and secondary outcomes will be compared in relation to the timing of the referral by the gynecologic oncologist (within 1 year or greater than 1 year out from the endometrial cancer/hyperplasia diagnosis).
  • Secondary outcomes of subjects included in this study will be compared to a historic cohort matches for age, stage and BMI in a 2:1 fashion.

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Weight Loss Referral; 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.

Behavioral: Weight Loss Specialist; Referred to a weight loss specialist; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Intervention; Other: Quality-of-Life Assessment; Complete EORTC-QLQ questionnaires; Other Names: Quality of Life Assessment; Other: Medical Chart Review; Chart reviews are performed; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual with intervention, defined as number of subjects who agree to participate	Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.	Up to 24 months
Compliance with intervention, defined as number of patients who follow up with the obesity referral	Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss (in kilograms)	Descriptive statistics will be used. Will compare groups using a paired t-test.	Baseline to 12 months
Weight loss (in kilograms)	Descriptive statistics will be used. Will compare groups using a paired t-test.	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)	Will be compared using chi square or fisher exact tests.	At 3 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)	Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.	Baseline
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)	Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.	At 12 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)	Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.	At 24 months
Progression free survival	Descriptive statistics will be used. Will be described with Kaplan Meier curves.	Up to 24 months
Overall survival	Descriptive statistics will be used. Will be described with Kaplan Meier curves.	Up to 24 months
Recurrence rate	Descriptive statistics will be used to detail cancer related outcomes (cancer recurrence, date and location of recurrence, cancer related death).	Up to 24 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24	Will compare groups using a paired t-test.	At 12 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24	Will compare groups using a paired t-test.	At 24 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Amelia Jernigan, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: December 17, 2014
• Primary Completion (Actual): May 18, 2015
• Study Completion (Actual): May 18, 2015

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Hyperplasia; Endometrial Hyperplasia; Endometrial Neoplasms
• Other Study ID Numbers: CASE13813 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-02477 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No