Optimising Cardiovascular Health in Endometrial Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
研究概览
简要总结
Women successfully treated for endometrial cancer remain at higher risk of dying than women without a history of the disease, predominately due to an excess risk of cardiovascular disease. Our previous work has shown that endometrial cancer survivors are more likely to have undiagnosed and undertreated cardiovascular risk factors than the general population, despite being seen regularly by medical professionals. This study aims to determine the impact of optimising modifiable cardiovascular risk factors in endometrial cancer survivors on their quality of life and to identify barriers to lifestyle modifications.
详细描述
A comprehensive cardiovascular risk assessment will be performed as part of clinical care on women previously treated for endometrial cancer at the study site. This will include a focused interview, examination to determine body mass index (BMI) and waist circumference, blood pressure, blood tests and a urine sample.
The blood tests will screen for diabetes and non-diabetic hyperglycaemia (HbA1c), renal impairment (full blood count- FBC, urea and electrolytes- U&E), non-alcoholic fatty liver disease and contraindication to statin therapy (liver function tests- LFT), hypercholesterolaemia (total, HDL and LDL cholesterol) and hypothyroidism (thyroid function tests- TFT). Urine samples will be used to screen for renal impairment using dipstick testing for microscopic haematuria and determination of albumin: creatinine ratio (ACR).
An individualised cardiovascular risk assessment will be undertaken using the QRISK3 score, which is assessed by virtue of the presence or absence of individual cardiovascular risk factors.
Based on these findings, an individualised management plan will be generated and appropriate treatment for any modifiable risk factors commenced in accordance with NICE (National Institute for Health and Care Excellence) and local guidelines. This will include advice and support with lifestyle modification, commencing medication if needed and referral to community or specialist clinics. This will be carried with close communication and in conjunction with the patient's general practitioner (GP).
Women will be followed up over a one year period to monitor their response and compliance to treatment and the impact this has on their quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous treatment for endometrial cancer within the last four years
- •Able to consent to participation in the study
排除标准
- •Currently undergoing treatment for endometrial cancer recurrence
- •Anticipated life expectancy <12 months
- •To cease routine surveillance in next 12 months
- •Not registered with a General Practitioner (GP)
研究组 & 干预措施
Endometrial cancer survivors
干预措施: Lifestyle modification (Behavioral)
Endometrial cancer survivors
干预措施: Cardiovascular Agents, Other (Drug)
Endometrial cancer survivors
干预措施: QRISK 3 Score (Other)
结局指标
主要结局
To assess the change in quality of life in endometrial cancer survivors by treating modifiable cardiovascular risk factors over a period of 12 months.
时间窗: Baseline, 3 months, 6 months and 12 months.
The cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) questionnaire focused on general well-being and quality of life. This questionnaire uses numeric indicators from 1 to 7, with a lower overall score meaning a worse outcome and a higher score meaning a better outcome.
次要结局
- To identify barriers to the implementation of lifestyle changes in endometrial cancer survivors.(Between 3 and 9 months.)
研究者
Emma Crosbie
Professor
University of Manchester