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

Stage II Uterine Corpus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342730
• Other study ID #: CASE13813
• Secondary ID: NCI-2014-02477CA
• Status: Completed
• Phase: N/A
• Start date: December 17, 2014
• Est. completion date: May 18, 2015

Study information

• Verified date: November 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 18, 2015
• Est. primary completion date: May 18, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Endometrial Hyperplasia With Atypia
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia
• Stage IA Uterine Corpus Cancer
• Stage IB Uterine Corpus Cancer
• Stage II Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Behavioral:
• Weight Loss Specialist
Referred to a weight loss specialist

Other:
• Quality-of-Life Assessment
Complete EORTC-QLQ questionnaires
• Medical Chart Review
Chart reviews are performed

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Weight loss (in kilograms)	Descriptive statistics will be used. Will compare groups using a paired t-test.	Baseline to 12 months
Secondary	Weight loss (in kilograms)	Descriptive statistics will be used. Will compare groups using a paired t-test.	Baseline to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Progression free survival	Descriptive statistics will be used. Will be described with Kaplan Meier curves.	Up to 24 months
Secondary	Overall survival	Descriptive statistics will be used. Will be described with Kaplan Meier curves.	Up to 24 months
Secondary	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
Secondary	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
Secondary	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