Clinical trial NCT02342730: Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia
Official title: Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Endometrial Hyperplasia With Atypia
Stage IA Uterine Corpus Cancer
Stage IB Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-21
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Accrual with intervention, defined as number of subjects who agree to participate
timeFrame: Up to 24 months
measure: Compliance with intervention, defined as number of patients who follow up with the obesity referral
timeFrame: Up to 24 months
Secondary outcomes:
measure: Weight loss (in kilograms)
timeFrame: Baseline to 12 months
measure: Weight loss (in kilograms)
timeFrame: Baseline to 24 months
measure: Compliance with lifestyle changes (based on affirmative response to 3 month follow up when asked if lifestyle changes have been adopted)
timeFrame: At 3 months
measure: Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
timeFrame: Baseline
measure: Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
timeFrame: At 12 months
measure: Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
timeFrame: At 24 months
measure: Progression free survival
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
measure: Recurrence rate
timeFrame: Up to 24 months
measure: Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
timeFrame: At 12 months
measure: Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
timeFrame: At 24 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Amelia Jernigan
role: PRINCIPAL_INVESTIGATOR
References: