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

NCT02342730 | Completed

• 3 other identifiers: CASE13813NCI-2014-02477P30CA043703
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Weight loss (in kilograms)

  Baseline to 12 months

• Weight loss (in kilograms)

  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)

  At 3 months

• Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)

  Baseline

• Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)

  At 12 months

Study Arms (1)

Weight Loss Referral

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.

Behavioral: Weight Loss Specialist; Other: Quality-of-Life Assessment; Other: Medical Chart Review

Interventions

Weight Loss Specialist BEHAVIORAL

Referred to a weight loss specialist

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Intervention

Weight Loss Referral

Quality-of-Life Assessment OTHER

Complete EORTC-QLQ questionnaires

Also known as: Quality of Life Assessment

Weight Loss Referral

Medical Chart Review OTHER

Chart reviews are performed

Also known as: Chart Review

Weight Loss Referral

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amelia Jernigan

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: December 17, 2014
• Primary Completion: May 18, 2015
• Study Completion: May 18, 2015
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

US (1)