Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Accrual with intervention, defined as number of subjects who agree to participate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Weight Loss Specialist (Behavioral)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Accrual with intervention, defined as number of subjects who agree to participate
时间窗: Up to 24 months
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
Compliance with intervention, defined as number of patients who follow up with the obesity referral
时间窗: Up to 24 months
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
次要结局
- Weight loss (in kilograms)(Baseline to 24 months)
- Progression free survival(Up to 24 months)
- Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)(At 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)
- Overall survival(Up to 24 months)
- Recurrence rate(Up to 24 months)
- Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24(At 24 months)