Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study

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Brief Title

Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.

      Self-management focusses on actions that people undertake for themselves to manage their
      health and illness. In order to self-manage, self-management support is needed (e.g. actions
      by healthcare professionals). Self-management has been shown to be effective in improving
      health outcomes such as quality of life. Skin self-examination can reduce mortality in
      melanoma. A meta-analysis of 18 trials of skin self-examination concluded that interventions
      including personalised phone counselling, whole body photographs and reminders to perform
      skin self-examination increased the number of events of patients examining themselves for
      skin cancer.

      A recent mixed-method study by the investigators has demonstrated that only 9% of women have
      been taught to self-examine, yet up to 86% self-examine regularly. Despite being motivated,
      50% reported a lack of confidence in recognition of vulval pathology and a high level of
      worry about their vulval condition. Both clinicians and patients agreed that face to face
      teaching was the best intervention for teaching vulval self-examination (unpublished).

      The overarching aim of the intervention is to support vulval self-examination in women at
      high risk of developing vulval cancer. The aims, processes and outcomes were agreed at the
      focus groups of both women with vulval conditions and clinicians.

      The structured intervention will include face-to-face training on vulval
      self-examination(VSE), supplemented with the use of aids including a hand-mirror or a
      selfie-stick. Women will be supported with reminders to self-examine, access to a telephone
      helpline and a leaflet on self-examination.
    


Study Type

Interventional


Primary Outcome

Change in number of self-reported vulval self-examination events

Secondary Outcome

 Change in Perceived Vulval Cancer Risk Score

Condition

Self-Examination

Intervention

Training in Vulval Self-Examination

Study Arms / Comparison Groups

 Single Arm Intervention
Description:  Participants will be shown how to perform vulval self-examination in a face-to-face intervention and provided with an information leaflet. They will be sent reminders to self-examine each month.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

25

Start Date

August 2021

Completion Date

December 2022

Primary Completion Date

February 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +441617017049, [email protected]



Administrative Informations


NCT ID

NCT04952961

Organization ID

295615


Responsible Party

Principal Investigator

Study Sponsor

University of Manchester

Collaborators

 British Society for the Study of Vulval Disease

Study Sponsor

, , 


Verification Date

July 2021