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

NCT ID: NCT02342730

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-17
• Study Completion Date: 2015-05-18

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Weight Loss Specialist

Intervention Type: BEHAVIORAL

Referred to a weight loss specialist

Quality-of-Life Assessment

Intervention Type: OTHER

Complete EORTC-QLQ questionnaires

Medical Chart Review

Intervention Type: OTHER

Chart reviews are performed

Interventions

Weight Loss Specialist

Referred to a weight loss specialist

Intervention Type: BEHAVIORAL

Quality-of-Life Assessment

Complete EORTC-QLQ questionnaires

Intervention Type: OTHER

Medical Chart Review

Chart reviews are performed

Intervention Type: OTHER

Other Intervention Names

Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Intervention; Quality of Life Assessment; Chart Review

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelia Jernigan

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2014-02477

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE13813

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE13813

Identifier Type: -

Identifier Source: org_study_id