跳至主要内容
临床试验/NCT04952961
NCT04952961已完成不适用

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

University of Manchester1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年11月4日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanitha Sivalingam

Academic Clinical Lecturer in Gynaecological Oncology

University of Manchester

研究点 (1)

Loading locations...

相似试验

进行中(未招募)
不适用
Primary Cervical Cancer Screening by Self-sampling HPV TestNegative For Intraepithelial Lesion Or MalignancyAtypical Squamous Cells of Undetermined SignificanceAtypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial LesionLow-Grade Squamous Intraepithelial LesionsCervical CancerHigh-Grade Squamous Intraepithelial LesionsCervical Intraepithelial Neoplasia Grade ICervical Intraepithelial Neoplasia Grade IICervical Intraepithelial Neoplasia, Grade IIIAtypical Glandular CellsAtypical Glandular Cells Not Otherwise SpecifiedAtypical Glandular Cells, Favor NeoplasticAdenocarcinoma in SituCervical AdenocarcinomaHuman Papillomavirus InfectionCervical Squamous Intraepithelial LesionCervical Squamous Cell Carcinoma
NCT05613283Peking University People's Hospital17,875
Unknown
不适用
Urinary and Vaginal HPV Testing in Cervical Cancer ScreeningUterine Cervical Neoplasms
NCT05065853University of Aarhus330
招募中
不适用
Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIVHPV Infection
NCT06507917Centre Hospitalier Universitaire de la Réunion398
Unknown
不适用
Clinical Evaluation of Detection of High Risk HPV in UrineHuman Papilloma VirusNegative for Intraepithelial Lesion or MalignancyAtypical Squamous Cells of Undetermined SignificanceCervical CancerHuman Papillomavirus InfectionAtypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial LesionLow-grade Squamous Intraepithelial LesionHigh-Grade Squamous Intraepithelial LesionsCervical Intraepithelial Neoplasia Grade ICervical Intraepithelial Neoplasia Grade IICervical Intraepithelial Neoplasia, Grade IIIAtypical Glandular CellsAtypical Glandular Cells Not Otherwise SpecifiedAtypical Glandular Cells, Favor NeoplasticAdenocarcinoma in SituCervical Squamous Intraepithelial LesionCervical AdenocarcinomaCervical Squamous Cell Carcinoma
NCT05210348Peking University People's Hospital1,000
进行中(未招募)
不适用
Cervical Cancer Screening With Human Papillomavirus TestingCIN3CIN2Cervical Cancer
NCT01881659International Agency for Research on Cancer50,000