Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study A Feasibility Study of Interventions to Promote Vulval Self-examination in Women at Increased Risk of Vulval Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in number of self-reported vulval self-examination events
研究概览
简要总结
Vulval cancer, while rare, has increased in incidence by 17% since the 1990s. It is strongly associated with age, thus this increasing trend is likely to continue with extended life expectancy. Vulval cancer is highly treatable when detected early. Women with chronic vulval conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia are at increased risk of developing vulval cancer. Most patients are in hospital follow-up, however regular vulval self-examination can pick up lesions earlier. There are no formalised methods of teaching self-examination and no evidence that it is acceptable to women.
The main objective of this study is to pilot an intervention to promote and support vulval self-examination for women at increased risk of vulval cancer including those with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia.
Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis.
详细描述
Vulval cancer is a rare gynaecological cancer, with an increasing incidence rate. IThis trend is expected to risk in years to come because of an aging populating and the increasing rate of human-papillomavirus-related vulval squamous cell carcinoma (VSCC) in young women.
Vulval cancer has a profound effect on the quality of life of women diagnosed with the disease. It carries both disease-related mortality risk and significant morbidity including lower limb lymphoedema, sexual dysfunction and groin discomfort.
Early detection of vulval cancer leads to improved survival and allows for conservative surgical treatment, lower morbidity and improved cosmesis. It is widely agreed that there is no role for screening the general population for vulval cancer; there are no systematic screening programmes nor are there reliable screening methods for identifying malignant precursors . The identification of vulval premalignant and malignant disease, therefore relies on the recognition and reporting of vulval symptoms by the patient and the knowledge and clinical acumen of the health care professional.
There is however, a population of women with chronic vulval conditions who are more likely to develop vulval cancer. Lichen sclerosus (LS), lichen planus (LP) and VIN are recognised precursors of vulval cancer. Regular follow-up in a specialist vulval clinic allows for evaluation of symptom control and treatment compliance and identification of early malignant change; however, regular vulval self-examination may prompt early diagnosis. The interval between noticing a symptom and seeking help could potentially be reduced by providing clear information on signs and symptoms of vulval cancer and guidance on monitoring skin-changes.
Secondary follow-up is not necessary for all women, and women with stable lichen sclerosis are often managed in primary care. Recent guidance from the British Association of Dermatology recommends that women with vulval LS who have responded to treatment be discharged to the care of their general practitioner after a twelve month follow-up period .However, as a majority of women discharged from UK vulval clinics are not subsequently followed up in primary care appropriately, it is important that women are able to self-examine and are confident in recognising and reporting suspicious symptoms. There is, however, no formalised method of teaching vulval self-examination and many women continue with secondary care input.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of a vulval condition with increased risk of malignancy ( lichen sclerosus, lichen planus or vulval intraepithelial neoplasia)
- •New diagnosis of a vulval condition with increased risk of malignancy ( lichen sclerosus, lichen planus or vulval intraepithelial neoplasia)
- •Must be able to provide informed consent
排除标准
- •Inability to consent or complete questionnaires due to cognitive or language issues
- •Inability of perform a vulval self-examination due to physical or visual impairments
- •Note: Those with physical or visual impairments can participate if a dyad is willing to learn how to perform a vulval examination
结局指标
主要结局
Change in number of self-reported vulval self-examination events
时间窗: 6 months
Change in number of self-reported vulval self-examination events over one month before and after the intervention. Patients are asked to record self-examination events in the patient diary
次要结局
- Change in Perceived Vulval Cancer Risk Score(6 months)
- Change in Vulval Cancer Worry Scale(6 months)
- Change in the Hospital anxiety and depression scale(6 months)
- Vulval quality of life index(6 months)
研究者
Vanitha Sivalingam
Academic Clinical Lecturer in Gynaecological Oncology
University of Manchester
